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Wong, S.F., Lindgren, A., Mummaneni, M., Byun, T., Vasko, C., Arenos, R., ... Osann, K. (2010). A prospective crossover pilot study to evaluate the use of a topical wound gel in patients with cutaneous toxicity caused by epidermal growth factor receptor inhibitors. The Journal of Supportive Oncology, 8, 202–208.

Study Purpose

To evaluate the effectiveness of Regenecare® Wound Gel in alleviating the pain and pruritus of EGFR-induced (EGFRI) rash

Intervention Characteristics/Basic Study Process

Enrolled patients received Regenecare® Wound Gel, a viscous hydrogel wound dressing with 2% w/w lidocaine. Facial assessments were conducted weekly for up to six weeks, and patient self-report questionnaires were collected weekly. Patients who developed grade 2 or higher rash applied the gel to the right side of the face three to four times per day for one week. In weeks 2–5, patients applied the gel three to four times per day to both sides of the face. Compliance data were collected at each visit, and patients whose adherence fell below 75% received specialized counseling. If patients were not adherent for two consecutive weeks, they were removed from the study.

Sample Characteristics

  • N = 13
  • MEDIAN AGE = 51.2 years
  • MALES: 54%, FEMALES: 46%
  • KEY DISEASE CHARACTERISTICS: Majority of patients had colorectal cancer and were receiving cetuximab.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Orange County, California

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care 

Study Design

Prospective, crossover

Measurement Instruments/Methods

  • CTCAE version 3.0 for Rash/Desquamation
  • Pain scale (none, mild, moderate, severe)

Results

When the right and left sides of the face were compared, the gel was associated with a significant reduction in pruritus (p = 0.01) but no significant decrease in pain level. The gel also had minimal effect on erythema and swelling as assessed by healthcare providers.

Conclusions

The hydrogel decreased pruritus associated with EGFR-inhibitor associated rash but did not have any influence on pain associated with the rash.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias(sample characteristics)
  • Findings not generalizable

 

Nursing Implications

Nurses should assess patients with EGFR-associated rash for pruritus, including intensity and the level to which it affects patient comfort. Regenecare® Wound Gel may be an effective topical intervention to relieve pruritus and should be considered for a topical treatment. There is no benefit to using the gel for pain relief, and nurses should consider other interventions if patients experience pain associated with the rash.

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Wong, R.K., Bensadoun, R.J., Boers-Doets, C.B., Bryce, J., Chan, A., Epstein, J.B., . . . Lacouture, M.E. (2013). Clinical practice guidelines for the prevention and treatment of acute and late radiation reactions from the MASCC Skin Toxicity Study Group. Supportive Care in Cancer, 21, 2933–2948. 

Purpose & Patient Population

PURPOSE: To develop evidence-based guidelines to prevent and treat skin toxicity (acute and late) from radiation therapy. Use of these guidelines was intended for practitioners who encounter patients with skin changes associated with radiation therapy.
 
TYPES OF PATIENTS ADDRESSED: Patients who have received or will receive radiation therapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline
 
PROCESS OF DEVELOPMENT: The Skin Toxicity Study Group is one of 17 study groups of the Multinational Association for Supportive Care in Cancer (MASCC). The first original search was from 1980–2004 and was used by the Cancer Care Ontario guideline group. This search was updated in 2010 for a book chapter on radiation dermatitis, including the original search strategy from 1980–2004 in addition to a search without language restriction for 2004–August 2010. For the MASCC guideline, a second update from 2010–April 2011 was conducted for the meeting. A final update was completed in July 2012 prior to publication of the manuscript.

DATABASES USED: MEDLINE for initial and subsequent updates; PreMEDLINE, Cochrane Library, and CANCERLIT for the original search 1980–2004; Embase for 2010–2012; and conference proceedings of the American Society of Clinical Oncology for 2004–2012. National Guidelines Clearinghouse was used for existing practice guidelines.

KEYWORDS: Radiation dermatitis for acute reactions; telangiectasia and cutaneous fibrosis for late reactions

INCLUSION CRITERIA: Randomized controlled trials, guideline papers, meta-analyses, and systematic reviews. Studies that included any control group met the definition of a controlled study. Inclusion required that grade of skin reaction was evaluated as an outcome with primary interest greater or equal to moist desquamation. Pain, itching, and quality of life also were included if available. For late reaction dermatitis, trials using prospective designs were used.

EXCLUSION CRITERIA: Unpublished articles

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Results Provided in the Reference

Acute radiation dermatitis recommendations were based on guidelines consisting of four general systematic reviews, two for specific topics, two evidence-based guidelines, and one consensus guideline. There were 56 randomized controlled trials–45 prevention, 9 treatment, and 1 combined prevention and treatment. Late radiation effect recommendations were based on one RCT; one prospective, observational study; and two prospective, single-arm studies.

Guidelines & Recommendations

Strong recommendation:
  • Gentle washing with water (mild soap or shampoo optional)
  • Antiperspirants during breast radiation therapy
  • Prophylactic topical steroids (mometasone) for risk reduction of discomfort and itching
 
Weak recommendation:
  • Prophylactic silver sulfadiazine cream in patients with breast cancer to reduce radiation dermatitis score
 
Strong recommendation against:
  • Prophylactic aloe vera or trolamine
 
No recommendation possible:
  • Prophylactic topical sulcrate/derivatives, hyaluronic acid, ascorbic acid, silver leaf dressing, LED, Theta-Cream, dexpanthenol, and calendula
  • Oral proteolytic enzymes, sucralfate, zinc, and pentoxifylline in standard clinical practice
 
Established radiation-induced telangiectasia and fibrosis:
  • Weak recommendation for pulse dye laser for visual appearance
  • Weak recommendation against pentoxifylline for reduction of fibrosis in standard clinical practice
 
Patient education materials:
  • Validation prior to use
  • Sixth grade reading level and tables preferred
  • Specific products to purchase with examples
  • Behaviors to avoid
  • Contact information for physician and when to call for symptom management

Nursing Implications

Nurses need to keep updated on current studies and guidelines related to care of patients receiving radiation therapy as well as potential acute and long-term effects to the skin. Nurses are in a unique position to educate staff and patients on evidenced-based skin care. Potential skin care practices for patients undergoing radiation need to be evaluated through well-designed research studies.

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Won, Y., Hwa, Choi, Y., Jung, Ahn, S., Lee, J., Park, J., Yun, Kim, S., . . . Kim, Y.H. (2014). Improving the quality of cancer pain management in an academic medical center emergency department. Clinical Journal of Oncology Nursing, 18, 626–629. 

Study Purpose

To evaluate the impact of a cancer-related pain control project implemented in a specialized cancer emergency department

Intervention Characteristics/Basic Study Process

A project to improve the management of cancer-related pain was implemented in a cancer emergency department that was established two years prior. The project used standard operating procedures for patient assessments every eight hours and reported any pain within one hour of analgesic administration. The pain management guidelines used included the use of oral analgesics following the World Health Organization analgesic ladder, the use of time-release analgesics for the prevention of pain recurrence, the prophylactic prescription of immediate-release analgesica for breakthrough pain, and the increase of the regular analgesic dose when breakthrough pain occurred more than three times per day. The target pain score on a numeric rating scale was established at three points or less. Medical records were reviewed to obtain study data, and adherence to the guideline and procedures was ranked low, medium, or high based on percent adherence. Findings prior to and after the project's implementation were compared.

Sample Characteristics

  • N = 455
  • MEAN AGE = 54.9 years
  • MALES: 50%, FEMALES: 50%
  • KEY DISEASE CHARACTERISTICS: The majority of patients had solid tumors of various types.
  • OTHER KEY SAMPLE CHARACTERISTICS: The patients included were those in the emergency department for at least 24 hours.

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Korea

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care

Study Design

Retrospective, descriptive study

Measurement Instruments/Methods

  • Pain severity Numeric Rating Scale (NRS)
  • Time to reaching target pain NRS score of three or less
  • Guideline adherence high (> 75 %), medium (50%–75%), and low (< 50%)

Results

The percentage of patients who received pain assessments according to the procedure increased after the intervention (p < 0.001). There was a significant improvement in the appropriate use of short-acting analgesics (p < 0.001), prescriptions for breakthrough pain analgesics (p = 0.013), and the use of time-release analgesics (p < 0.001). The time to reach the target NRS was 27 hours before the intervention and 15 hours after (p = 0.025). There was a significant correlation between guideline adherence and time to reach the target NRS score (p = 0.039).

Conclusions

The use of standard guidelines and standard operating procedures for the treatment of cancer-related pain was associated with improved frequency of assessment and time to reach a target pain score.

Limitations

  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Other limitations/explanation: The intervention was done in a cancer-specific emergency department. Such a specialized emergency department is not usual. There was no description of how the project and its related changes in practice were actually implemented or what staff education efforts were done to implement the guidelines and procedures.

Nursing Implications

The findings of this study suggest that organizational initiatives to improve pain control with guidelines and standard operating procedures can improve the management of cancer-related pain.

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Wolf, S.L., Qin, R., Menon, S.P., Rowland, K.M., Jr, Thomas, S., Delaune, R., . . . Loprinzi, C.L. (2010). Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. Journal of Clinical Oncology, 28, 5182–5187.

Study Purpose

To determine the effectiveness of a urea/lactic acid–based topical keratolytic agent (ULABTKA) for the prevention of capecitabine-induced hand-foot syndrome (HFS).

Intervention Characteristics/Basic Study Process

Eligible patients received their first dose of capecitabine at 2,000 or 2,500 mg/m2 per day for 14 days, every 21 days. Patients then were randomized to the ULABTKA arm or placebo cream. Creams were applied to the hands and feet BID for 21 days over four consecutive cycles. Patients kept a daily diary. Toxicity data were collected at baseline and the end of each 21 day cycle. The primary end point was incidence of moderate or severe HFS in the first cycle, based on patient report. Secondary end points included the incidence of moderate or severe HFS by physician grading, times to grade, and physician determination.

Sample Characteristics

  • The study reported on a sample of 127 patients. Of 137 total patients enrolled, only 67 on study drug and 60 on placebo reported characteristics and outcomes.
  • Twenty patients were aged younger than 50 years, 36 were aged from 50 to 60 years, and 71 were aged older than 60 years.
  • The sample was 84% female, 16% male, and 96% Caucasian.
  • Sixty-five percent of the sample had breast cancer, 23% had lung cancer, and 11% had colon cancer.
  • All patients were to receive their first cycle of capecitabine; 85% were on metastatic treatment and 14% were on adjuvant treatment.

Setting

  • Multi-site
  • Outpatient
  • North Central Cancer Treatment Group (NCCTG)

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a randomized, double-blind, phase 3 clinical trial.

Measurement Instruments/Methods

  • All patients were provided information regarding initial signs and symptoms of HFS.
  • Patients completed a self-reported HFS diary daily.
  • Physicians determined HFS grades for symptoms with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, at baseline and the end of each 21-day cycle.
  • Patients completed a symptom experience diary at baseline and each week.
  • Patients were queried about the occurrence of rash and diarrhea at each visit.

Results

  • No significant differences were observed in toxicities between the two groups across all visits.
  • With regard to primary end point, the difference between the two study arms was not statistically significant. In fact, the incidence of moderate-to-severe HFS was higher in the treatment arm.

Conclusions

The use of urea/lactic acid for the prevention of HFS in patients receiving capecitabine therapy cannot be supported on the basis of this trial.

Limitations

The primary end point only concerned the first 21-day cycle, rather than looking over the planned four cycles. This raises the question over whether more power could have existed to detect smaller differences. More patients received the lower dose of capecitabine.

Nursing Implications

Nurses should educate patients to limit or not use urea/lactic acid cream if starting on capecitabine.

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Wolf, H.H., Leithäuser, M., Maschmeyer, G., Salwender, H., Klein, U., Chaberny, I., Weissinger, F., . . . Infectious Diseases Working Party of the German Society of Hematology and Oncology. (2008). Central venous catheter-related infections in hematology and oncology: Guidelines of the Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO). Annals of Hematology, 87, 863–876.

Purpose & Patient Population

To identify risk factors for developing catheter-related infections (CRIs) and interventions to prevent CRIs in patients with central venous catheters (CVCs)

 

Type of Resource/Evidence-Based Process

The guidelines were developed by reviewing studies to identify populations at risk and interventions effective in preventing CRIs. Key words searched included catheter-related infections, guidelines, neutropenia, antimicrobial treatment, infection prophylaxis, and biofilm.

Results Provided in the Reference

Strict procedures for hygiene during insertion of CVCs are effective in avoiding infections. CVC insertion through the subclavian vein rather than the internal jugular is better for preventing infections, but other risks, including severe hemorrhage, need to be assessed.  

For dressing changes and insertion site prep, chlorhexidine solution is preferred over aqueous polyvidone-iodine solutions, and alcoholic chlorhexidine solution, alcoholic polyvidone solutions, or 70% propranolol are alternatives noted to be safe. One randomized, controlled study showed that using alcoholic chlorhexidine in sequence with aqueous polyvidone-iodine was superior to using them as single agents.

Routine catheter replacement, systemic prophylactic antibiotic therapy prior to catheter insertion, and applying antibiotic ointment to the catheter site all show no benefit in preventing infections. Sterile gauze dressing changes every two days and transparent film dressings changed weekly are recommended in the absence of inflammation or loss of dressing integrity, but more frequent dressing changes do not reduce CRIs.

Infusion tubing is recommended to be changed every 72 hours with the exception of systems used for lipid emulsions recommended to be changed every 24 hours. Transfusion tubing should include standard filters for red blood cells or platelets and German regulations are specific about filter changes every six hours, noting that replacing filters at earlier intervals does not lower infection rate. Only one randomized trial of patients with cancer with nontunneled minocycline/rifampin-coated CVCs reported a decrease in bloodstream infections that were catheter-related. Recent randomized studies do not show a correlation between CRIs and the number of catheter lumen, as reported by earlier nonrandomized studies recommending single-lumen catheters.

Guidelines & Recommendations

Recommendations include

  • Adhering to hygiene principles when inserting CVCs and employing standardized aseptic placement, using subclavian vein versus internal jugular vein for vascular access, and using catheters impregnated with antiseptics like chlorhexidine/silver sulfadiazine or antibiotics including minocycline/rifampin have been effective in reduction of catheter colonization. 
  • Educating nurses and physicians.
  • Using ultrasound guidance during insertion. 

Routine replacement of catheters is not effective in reducing CRIs. Antibiotic ointment at insertion site or applied to nostrils is not recommended. Systemic antibiotics are not recommended prior to CVC insertion as prophylaxis.

Limitations

  • No conflict of interest concerns were addressed.

Nursing Implications

Age (pediatrics), grade of neutropenia, catheter type, disease diagnosis, nurse-to-patient ratio, administration of parental nutrition, and number of days the patient has the CVC may all contribute to the risk of developing CRIs. It was suggested in two studies that in the hematologic/oncologic population, subclinical thrombosis of the catheterized vein as seen on ultrasound could be a significant risk factor for developing CRIs. Although some of the studies show benefit of antibiotic flushes to reduce CRIs, there are no prospective randomized, double-blind studies involving adults or pediatric patients with hematologic or solid tumors to determine if this practice will result in development of resistant bacteria. Although recommendations were shown in text and table using the A–E, I–III grading and evidence, no definitions or key were presented in this article.

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Wohlrab, J., Bangemann, N., Kleine-Tebbe, A., Thill, M., Kummel, S., Grischke, E.M., . . . Luftner, D. (2014). Barrier protective use of skin care to prevent chemotherapy-induced cutaneous symptoms and to maintain quality of life in patients with breast cancer. Breast Cancer, 6, 115–122. 

Study Purpose

To test the effectiveness of a topical application of a niacinamide-containing, barrier-protective preparation in women with breast cancer undergoing treatment with anthracyclines or taxanes

Intervention Characteristics/Basic Study Process

This prospective, randomized, reference-controlled crossover study began on the first day of chemotherapy. One study group (group 1) received the test preparation (TP) for six weeks then standard care (SC) for six weeks. Group 2 started with six weeks of SC then crossed over to six weeks of TP. TP consisted of a shea butter lipophilic cream containing 4% niacinamide and thermal spring water from La Roche-Posay as the hydrophilic phase (Lipikar Baume AP®; La Roche-Posay Laboratoire Pharmaceutique, La Roche-Posay, France). TP was applied twice daily on the whole body. SC consisted of patients' usual body care. This was used as the control arm. Data were collected for 12 weeks.

Sample Characteristics

  • N = 73
  • AGE RANGE = 25–77 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients who were diagnosed with breast cancer and who were scheduled to receive taxane or anthracycline chemotherapy in an adjuvant or neoadjuvant setting with or without trastuzumab
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients could not have dysfunctional skin barrier signs, atopic or psoriatic skin history, or have been prescribed or using over-the-counter compounds with vasoactives, anti-inflammatory agents, diuretics, or medications affecting lipid metabolism.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Not specified    
  • LOCATION: Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care  

Study Design

Multicenter, prospective, randomized, reference-controlled crossover study

Measurement Instruments/Methods

  • The Dermatology Life Quality Index (DLQI): Six DLQI subscales were included in the analysis.
  • Symptoms of pruritus, dryness, and skin irritability were quantified using a Visual Analog Scale (VAS).

 

Results

Total DLQI scores after six weeks were not significantly different. There was a significant difference on the “symptoms and feelings” DLQI subscale after week 4 (p = .06). Secondary parameters of pruritus (p = .034), dryness (p = .0002), and irritability (p = .0312) revealed significant differences for TP after six weeks.

Conclusions

Anthracyclines and taxanes cause dry, itchy skin. Total DLQI scores indicated that the treatment was not superior to the control in preventing skin toxicities associated with anthracycline and taxane therapy in women with breast cancer. Results from the VAS indicated that the experimental treatment may improve pruritus, dryness, and skin irritability. No safety concerns were raised by participants in this trial.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: This study, although randomized, was not blinded. Measurement tools were discussed but not provided. Dropout rates were caused by patients stopping chemotherapy. This study was not generalizable due to the homogeneity of the sample.

Nursing Implications

Skin and cutaneous side effects from chemotherapy affect the quality of life of patients dealing with cancer diagnoses. The ability to suggest proactive interventions gives healthcare providers the opportunity to promote patient independence and show an understanding of patients' physical and social needs. Without untoward effects, it would seem appropriate to suggest niacinamide-containing creams as a possible preventive treatment for skin care during chemotherapy with anthracyclines or taxanes to decrease dryness, pruritus, and skin irritability in this population. Nurses should share the limitations of this study when discussing the evidence it produced. Research on this compound in patients with other diagnoses using these chemotherapy agents could strengthen the level of evidence.

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Wiskemann, J., Dreger, P., Schwerdtfeger, R., Bondong, A., Huber, G., Kleindienst, N., . . . Bohus, M. (2011). Effects of a partly self-administered exercise program prior to, during, and after allogeneic stem cell transplantation. Blood, 117, 2604–2613.

Study Purpose

The primary aim was to identify the benefits of exercise performed during the entire hematopoietic stem cell transplantation (HSCT) time period. The secondary aim was to explore endurance performance via six-minute walk test (6MWT), isometric muscle strength, functional performance status, physical activity levels via pedometer step count, health-related quality of life, and psychological well-being and distress.

Intervention Characteristics/Basic Study Process

A self-administered exercise intervention was compared to a social contact pedometer-wearing control group. Exercise began one to four weeks prior to hospital admission. Exercise included three endurance (outpatient:  walking; inpatient:  bicycling and treadmill) and two resistance (color-coded bands with different levels of resistance focused on extremities, entire body, and bed exercises) training sessions per week (up to five sessions during hospitalization). Exercise continued six to eight weeks after discharge. The control group reported that moderate physical activity was helpful without instruction, wore step counters, and received thirty minutes of physiotherapy and access to bicycles and treadmills during hospitalization. Both groups received the same number of visits by study personnel.

Sample Characteristics

  • One hundred five patients were enrolled, and 80 (40 in each group) were included in the final analysis.
  • Mean age was 48.8 years. 
  • Thirty-four females and 71 males were included. 
  • Patients had acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), myelodysplastic syndrome (MDS), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), lymphoma, and aplastic anemia.

Setting

  • Multisite
  • University Clinic, Heidelberg, Germany and the German Diagnostic Clinic, Wiesbaden, Germany

Study Design

This was a prospective, multicenter, randomized, controlled trial.

Measurement Instruments/Methods

  • Borg Scale – perceived exertion scale
  • Multidimensional Fatigue Inventory (MFI)
  • Profile of Mood States (POMS)
  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Daily log
  • 6MWT protocol by the American Thoracic Society estimated aerobic capacity
  • Hand-held dynamometer measured maximal isometric voluntary strength
  • National Comprehensive Cancer Network (NCCN) Distress Thermometer
  • Hospital Anxiety and Depression Scale (HADS)

All assessments were measured at four time points:  baseline, admission, discharge, and six to eight weeks after discharge.

Results

Significant group differences at the end of the intervention were:  general fatigue (p = 0.009); physical fatigue (p = 0.01); and POMS fatigue scale (p = 0.004). The exercise group was superior to the control group in all subscales. Physical capacity increased in the exercise group (p = 0.02) and was inversely correlated with general fatigue (p ≤ 0.01). The Intervention significantly improved the strength of the lower extremities (p = 0.03) (maybe due to walking and biking). The exercise group was significantly more anxious than the control group (p = 0.007). All benefits were observed most predominantly during hospitalization.

Conclusions

This partly supervised exercise intervention was beneficial for patients undergoing allogeneic (allo)-HSCT.

Limitations

  • The study had a small sample size, with less than 100 patients. 
  • The 6MWT was not a standard procedure for assessing endurance capacity.
  • Interrater reliability was unknown for the hand-held dynamometer.
  • Exercise logs were missing (most before and during hospitalization).
  • There was no documentation about social support for the control group.

Nursing Implications

The allo-HSCT patient population should be encouraged to exercise. An exercise intervention is feasible and can alter cancer-related fatigue in the allo-HSCT patient population. Use of preadmission exercise in concert with findings of differences in fatigue between individuals who have higher baseline activity levels suggests that further research in improving capacity and activity levels prior to treatment in various patients is worth investigating.

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Wirz, S., Wittmann, M., Schenk, M., Schroeck, A., Schaefer, N., Mueller, M., . . . Nadstawek, J. (2009). Gastrointestinal symptoms under opioid therapy: A prospective comparison of oral sustained-release hydromorphone, transdermal fentanyl, and transdermal buprenorphine. European Journal of Pain, 13, 737-743.

Study Purpose

To determine whether the transdermal opioids transdermal fentanyl (TDF) or transdermal buprenorphine (TDB) or oral sustained-release hydromorphone (OSRH) produced different gastrointestinal side effects.

Intervention Characteristics/Basic Study Process

Patients with nociceptive pain receiving one of the study drugs (TDF, TDB, or OSRH) over four weeks at a stable dose were identified. Medication adherence was checked daily.

Sample Characteristics

  • The study reported on a sample of 174 patients.
  • Mean patient age was 64.1 years (SD =11.6) in the TDF group, 65.3 years (SD = 10.7) in the TDB group, and 67.8 years (SD = 11.2) in the OSRH group.
  • The sample comprised 27 women and 28 men in the TDF group, 25 women and 36 men in the TDB group, and 24 women and 34 men in the OSRH group.
  • Patients were experiencing cancer-related pain.

Setting

  • Single site
  • Outpatient
  • Germany

Phase of Care and Clinical Applications

Not applicable

Study Design

This was a prospective, open-label, controlled study.

Measurement Instruments/Methods

  • Eastern Cooperative Oncology Group (ECOG) performance status
  • Selected European Organization for Research and Treatment of Cancer (EORTC) questionnaire items to assess constipation
  • Numeric Rating Scale (NRS)
  • Medications
  • Physical assessments daily for five days

Results

  • No difference existed between the groups in mean intensity scores for constipation.
  • Patients in the TDF group experienced slightly more constipation.
  • No difference existed between groups in laxative use.
  • TD narcotics caused more constipation than oral medication in this study.

Conclusions

TD narcotics caused more constipation than oral hydromorphone.

Limitations

  • The study lacked an appropriate control group.
  • Although this study disclosed the types of laxatives used, it did not differentiate whether one substance could have been more beneficial than another.

Nursing Implications

In this study, TD narcotics caused more constipation than the oral narcotic.

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Wirz, S., Nadstawek, J., Elsen, C., Junker, U., & Wartenberg, H.C. (2012). Laxative management in ambulatory cancer patients on opioid therapy: A prospective, open-label investigation of polyethylene glycol, sodium picosulphate and lactulose. European Journal of Cancer Care, 21, 131–140.

Study Purpose

To determine whether variable effectiveness exists in the use of polyethylene glycol (PEG), sodium picosulphate (SPS), and lactulose in ambulatory outpatients with cancer on opioid therapy.

Intervention Characteristics/Basic Study Process

Eligible patients were assigned to three treatment groups. A fourth group comprised patients who had discontinued laxative therapy (NL). Laxative groups were treated for a minimum of 28 days prior to data collection with mu agonist and assigned laxative. Prescribers were free to choose the laxative. The standard doses were PEG 13.1 g per day, SPS 10 mg per day, and lactulose 10 g per day. An increase in dose was allowed if participants were directed to do so by the prescriber.

During the five-day data collection phase, investigators assessed participants daily on mobility and pain assessment. Constipation was assessed by documentation of defecation rates, number of participants with lack of bowel movement for more than 72 hours, subjective intensity of constipation using a numeric scale, and consumption of laxatives.

Average defecation rate of all patients was calculated as defecations per patient per five days. The number of patients reporting nausea or emesis also was documented. The daily doses of the original opioid (oral morphine, hydromorphone, oxycodone, tramadol, or transdermal fentanyl) were transferred into morphine equivalent doses for uniform comparison.

Sample Characteristics

  • The study reported on a sample of 348 patients.
  • Mean patient age was 62.4 years in the PEG group, 62.2 years in the SPS group, 65.6 years in the lactulose group, and 58.3 years in the NL group.
  • Demographic and medical data were similar in all groups.
  • The sample was 60% male and 40% female.
  • Key disease characteristics were cancer-related pain, opioid therapy with mu agonists (equivalent doses of oral morphine, hydromorphone, oxycodone, tramadol, or transdermal fentanyl), ambulatory treatment, patient cooperation, and Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3.
  • Patients were excluded from the study if they had used opioid antagonists, been referred for nonambulatory treatment, diarrhea at the beginning of therapy, disease likely to cause diarrhea (e.g., pancreatic cancer), opioid dose variations, conditions linked to opioid dose variations (e.g., breakthrough pain), communication deficits, hepatic or renal impairment, current chemotherapy or radiation therapy, nonambulatory status, terminal stage of disease, infection, prior history of drug or alcohol addiction or abuse, concurrent treatment with laxatives other than study medication, used more than a single laxative, partial agonists, and antagonist/agonist combinations.

Setting

  • Single site
  • Outpatient
  • Pain Clinic, University Hospital, Bonn, Germany

 

Phase of Care and Clinical Applications

  • Patients were undergoing chronic pain management for cancer diagnoses.
  • The study has clinical applicability for palliative care.
     

Study Design

This was a controlled, prospective, open-label study.

Measurement Instruments/Methods

  • ECOG Performance Status for mobility
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) for pain assessment
  • Constipation Assessment Tool
  • Numerical Rating Scale (NRS) for constipation and pain

 

Results

  • No patients in the study discontinued opioid therapy.
  • NRS values for pain were comparable in all groups.
  • After 28 days, PEG was the most frequently used laxative (n = 95, 27.3%) compared to SPS (n = 36, 10.3%) and lactulose (n = 32, 9.2%).
  • Fifty-three percent of patients (n = 185) discontinued laxative therapy.

Conclusions

In this prospective study, PEG was more frequently prescribed than SPS and lactulose. However, the data did not prove the superiority of PEG over SPS and lactulose for the management of constipation in ambulatory patients with cancer on opioid therapy.

Limitations

  • The study took place at a single site and may be biased in that respect.
  • No data exist to support whether opioid-induced constipation is dose-related or substance-related.
  • Daily opioid doses in study groups differed significantly (p = 0.011).
  • Medications were not blinded.
  • Physician preference of PEG over SPS and lactulose may show bias.
  • Some antiemetics used may have constipating effects.

Nursing Implications

No recommendation can be made.

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Winningham, M.L., & MacVicar, M.G. (1988). The effect of aerobic exercise on patient reports of nausea. Oncology Nursing Forum, 15, 447-450.

Study Purpose

To evaluate the therapeutic value of exercise to control or reduce nausea in patients with breast cancer receiving chemotherapy

Intervention Characteristics/Basic Study Process

Subjects were randomized to one of three groups.

  • The experimental exercise group participated in a 10-week supervised program with a cycle ergometer and aerobic and interval training three times per week.
  • In the placebo group, subjects met with exercise leaders on a weekly basis for conversational interaction and the mild stretching and flexibility exercises, which the experimental group also had performed during warm-up and cool down.
  • The control group received no treatment, but patients were instructed to continue normal activities and notify study personnel if they began exercising.

Sample Characteristics

  • The study consisted of 42 women with breast cancer.
  • The mean age of patients was 46 years.
  • No race or ethnicity data were recorded.
  • All patients were receiving chemotherapy (no doxorubicin), had had surgical treatment (mastectomy or lumpectomy), did not have uncontrolled cardiac disease or hypertension, were within the first six months of chemotherapy, and had had three treatments before entering the program.
  • Functional capacity at baseline was 0-2 Zubrod score or Karnofsky Performance Status of 60%–100%.
  • No participants were in an exercise program, and all were medically cleared by an oncologist.

Setting

  • Participants were from a large Midwestern city.
  • Patients were recruited from outpatient clinics, private practices, and a university medical center.

Study Design

The design was randomized, with three groups and pre- and post-test measures.

Measurement Instruments/Methods

Pretest to post-test nausea responses were coded as improved, no change, or worsened as reported on the Derogatis Symptom Checklist-90-Revised, a 5-point distress/somatization scale. This somatization scale has 12 items and includes a variety of symptoms common to medical patients.

Results

The differences among the experimental, control, and placebo groups were statistically significant, with the experimental group showing marked improvement in nausea compared to the control and placebo groups. The experimental group showed significant improvements in the Somatization scale scores (i.e., perceptions of autonomically mediated symptoms) over the control and placebo groups.

Limitations

  • The study was restricted to women with breast cancer who were on a specific aerobic exercise protocol; therefore, the study is not generalizable to other groups with cancer.
  • One cannot assume that other exercise techniques will generate the same results.
  • Patients with a history of hypertension or cardiac disease were excluded.
  • No patients receiving doxorubicin were admitted into the study.
  • Exercise testing was monitored by a physician.

Nursing Implications

Moderate aerobic exercise may provide some benefit in reducing nausea. Researchers recommended that patients abstain from exercise several hours prior to blood testing and on days of treatment.

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