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Ryu, J.K., Swann, S., LeVeque, F., Scarantino, C.W., Johnson, D., Chen, A., et al. (2007). The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: A double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. International Journal of Radiation Oncology, Biology, Physics, 67(3), 643–650.

Intervention Characteristics/Basic Study Process

Subcutaneous GM-CSF (250 mcg/m2) was started one week before radiation and stopped two weeks after completion. GM-CSF was given within two hours after each radiation fraction on Monday, Wednesday, and Friday. Doses were held on days that patients received chemotherapy.

Sample Characteristics

Patients with head and neck cancer with radiation ports on 50% or more of oral cavity or oropharynx to 60-70 Gy.

GM-CSF: n = 63
Placebo: n = 58

Setting

October 2000-September 2002
 

Measurement Instruments/Methods

  • CTC acute toxicity scale
  • Severity and duration of mucositis
  • Quality of life (QOL): University of Washington Head and Neck symptom questionnaire
     

Results

No statistical differences in mucositis or QOL scores

Limitations

Some participants discontinued study because of unspecified “toxicity”. Drug supply ended before all patients completed therapy.

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Ryan, J.L., Heckler, C.E., Roscoe, J.A., Dakhil, S.R., Kirshner, J., Flynn, P.J., … Morrow, G.R. (2012). Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: A URCC CCOP study of 576 patients. Supportive Care in Cancer, 20, 1479-1489.

Study Purpose

To determine the dose and efficacy of ginger at reducing the severity of chemotherapy-induced nausea (CIN) on day one of chemotherapy

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to four arms.

  • Placebo
  • 0.5 g ginger
  • 1.0 g ginger
  • 1.5 g ginger

Nausea occurrence and severity were assessed at a baseline cycle and the two following cycles during which patients were taking their assigned study medication. All patients received a 5-HT3 receptor antagonist antiemetic on day one of all cycles. Patients took three capsules of ginger (250 mg) or placebo twice daily for six days starting three days before the first day of chemotherapy. Patients reported the severity of nausea for days 1–4 of each cycle, four times daily.  Compliance was determined by pill counts.

Sample Characteristics

  • The sample consisted of 576 patients.
  • Mean age was 53 years.
  • The sample was 91% female.
  • All participants had been diagnosed with cancer and were receiving chemotherapy.
  • All patients had to have experienced nausea in a previous chemotherapy cycle and be scheduled to receive a 5-HT3 plus dexamethasone for antiemetic management. 
  • Baseline values showed that more than 50% of the sample had had previous chemotherapy. Baseline nausea ranged from 2.2–2.5.

Setting

This was a multisite study conducted at 23 private practice oncology groups  affiliated with the University of Rochester.

Phase of Care and Clinical Applications

  • Patients were in mutliple phases of care.
  • Applications exist for palliative care.

Study Design

This was a phase II/III randomized, double blind, placebo-controlled clinical trial.

Measurement Instruments/Methods

  • Nausea and emesis were measured on a 7-point scale using a modified four-day patient report diary developed by Burish and Carey.
  • A 13-item Symptom Inventory was used to assess potential side effects of ginger, as well as anticipatory nausea, on an 11-point scale.
  • Anticipatory nausea was analyzed using the nausea item on the Symptom Inventory completed prior to chemotherapy.
  • Quality of life was assessed using the 27-item Functional Assessment of Chronic Illness Therapy-General (FACIT-G) at baseline and follow-up assessments .

Results

  • No significant differences were found between the treatment arms in regard to the use of antiemetics.
  • The mixed model analyses across both study cycles 2 and 3 revealed that all doses of ginger significantly reduced acute CIN in both study cycles compared to placebo (p = 0.013, 0.003). Differences in the least-squares means showed that 0.5 g and 1.0 g daily ginger were the most effective at reducing acute nausea.
  • Data suggested that patients reported more severe delayed nausea compared to acute nausea, and no differences were found between groups in delayed nausea.
  • Overall, no significant differences were observed in vomiting or quality of life between the three ginger arms and placebo.
  • The majority of patients did not report episodes of vomiting (mean incidence = 0.5). 
  • Analysis revealed that anticipatory nausea (p < 0.0001) was a factor in acute CIN.
  • A total of 24 adverse events were reported during the course of the study. Only nine of the reported adverse advents were considered to be related to study drug.

Conclusions

Ginger given at 0.5 g-1.0 g daily, may aid in the reduction of acute-phase CIN in patients receiving standard antiemetics. The ability to clearly interpret results is difficult because of lack of information on chemotherapy agents involved and differences in antiemetic regimens used.

Limitations

  • The chemotherapy agents used were not described, so the emetogenicity of the treatment or potential differences between groups, which could have affected results, are not known. 
  • No discussion was provided regarding use or non-use of rescue medications or any other management strategies that may have been used.
  • The antiemetic regimens used were varied, and it is known that different regimens have different levels of effect. 
  • Though inclusion criteria identified use of 5-HT3 medication, results reported show that four different types of regimens were actually employed.

Nursing Implications

This study showed that ginger significantly reduced nausea in these patients during the acute phase but had no apparent effect on delayed nausea. Studies in the use of ginger have had mixed results, and meta analysis have shown no effect, in contrast to this study. Here, only nausea was examined, which may partially explain differences. Application of these findings is difficult, because the chemotherapy regimens used are not described, so emetogenicity or differences in regimens between groups cannot be evaluated. Also, the antiemetic medications used were varied and subgroup analysis was not done; how this influenced findings is not clear. Even with maximum current pharmacologic management of chemotherapy-induced nausea and vomiting, control of nausea, as opposed to vomiting, has remained problematic. Further research in approaches to effectively manage nausea, as well as emesis is needed.

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Rutkowski, A., Zajac, L., Pietrzak, L., Bednarczyk, M., Byszek, A., Oledzki, J., . . . Chwalinski, M. (2014). Surgical site infections following short-term radiotherapy and total mesorectal excision: Results of a randomized study examining the role of gentamicin collagen implant in rectal cancer surgery. Techniques in Coloproctology, 18, 921–928. 

Study Purpose

To determine the risk of surgical site infection (SSI) reduction using local gentamicin collagen implants (GCIs) following preoperative radiotherapy and total mesorectal excisions (TMEs)

Intervention Characteristics/Basic Study Process

  • Short-term radiotherapy (5 x 5 Gy) for rectal cancer preoperatively
  • A GCI was inserted into the wound after surgical excision and prior to the closure of the cavity.

Sample Characteristics

  • N = 176   
  • MEAN AGE = 63 years
  • MALES: 63.3%, FEMALES: 32.7%
  • CURRENT TREATMENT: Combination radiation and chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Rectal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Preoperative radiation (XRT), then surgery within six days post XRT, but pushed out to 6–8 weeks if necessary

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Warsaw, Poland

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics, elder care

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • SSI definition included superficial and organ space infections as defined by the Centers for Disease Control and Prevention (CDC)
  • Intrabdominal infections defined according to the Scottish Surveillance of Healthcare Associated Infection Program (e.g., cultures, abcesses, or other evidence of infection based on fever, symptoms, and diagnostic tests)

Results

No statistically significant differences existed between the study and control groups in early postoperative complications (25.6% and 34.1%, respectively, p = 0.245). The reoperation rate was similar in both groups: 12.8% versus 9.4%, p = 0.628, risk ratio [RR] = 1.359, 95% confidence interval [CI] [0.575, 3.212]. The total rate of SSI and organ space SSI were 22.2% and 15.8% without differences between the study and control groups. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received the GCI: 2.6% versus 13%, p = 0.018.

Conclusions

Inconclusive: Applying the GCI in the pelvic cavity after short-term preoperative XRT and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.

Limitations

Postoperative complications were a secondary aim and, therefore, the study lacked adequate power. Fewer patients received GCI because of a protocol deviation. Organ space SSI was not confirmed by bacteriological swabs. Sometimes, SSI was determined by a CT or physical symptoms and, therefore, could be misconstrued as infection when it was really an inflammatory reaction. This suggests that anastomotic leakage is such a significant risk factor for organ space SSI that the application of GCI does not prevent it. Patients were not given preoperative antibiotics, which is a current standard of care.

Nursing Implications

Nursing implications for this are clearly good surgical patient care postoperatively, such as using the aseptic technique while changing dressings; encouraging walking to prevent pneumonia; and teaching good nutrition for healing and excellent handwashing. The actual test depends on the surgeon’s suturing and excising techniques to prevent leakage. This study did not provide strong evidence for the use of CGIs to prevent SSIs.

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Rustøen, T., Valeberg, B.T., Kolstad, E., Wist, E., Paul, S., & Miaskowski, C. (2014). A randomized clinical trial of the efficacy of a self-care intervention to improve cancer pain management. Cancer Nursing, 37, 34–43. 

Study Purpose

To evaluate the efficacy of a psychoeducational nursing intervention for pain management on pain outcomes

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to control or intervention groups. The intervention was a version of the PRO-SELF pain control program adapted from the work of Miaskowski et al. A specially trained oncology nurse visited patients in their homes on weeks 1, 3, and 6, and did telephone interviews on weeks 2, 4, and 5. Individual patient knowledge deficits were identified based on responses on the pain experience scale, and educational information was tailored to meet individual needs. Patients were given written instructions about pain and the management of adverse effects, and they were taught how to use a weekly pill box and how to use a script to communicate with their physicians about unrelieved pain. During telephone contact, education was reinforced and patients were coached about how to modify pain management or contact the physician to improve pain outcomes. Home visits also involved additional coaching and ongoing education. Patients in the control group were given a booklet about cancer-related pain management and received home visits and telephone interviews with the same timing, focusing on encouraging patients to maintain a pain diary. Pain assessments were done during telephone interviews. The principal investigator listened to tapes of the intervention and control group nurses to ensure the fidelity of the intervention and control conditions.

Sample Characteristics

  • N = 147
  • MEAN AGE = 65.5 years
  • MALES: 52%, FEMALES: 48%
  • KEY DISEASE CHARACTERISTICS: Various tumor types; breast and prostate cancer were most frequent. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Baseline average pain score was 3.6 and worst pain scores were 5; greater than 50% reported breakthrough pain, and about 50% had been in pain for seven months or more; average daily intake of oral morphine equivalents was 190 mg 

Setting

  • SITE: Single site  
  • SETTING TYPE: Home  
  • LOCATION: Norway

Phase of Care and Clinical Applications

  • APPLICATIONS: Palliative care 

Study Design

Randomized, controlled trial with attention control

Measurement Instruments/Methods

  • Patients kept daily diary of numeric ratings of pain for least, average, and worst pain and whether they had breakthrough pain episodes.  
  • Daily opioid doses were also recorded in the diaries.

Results

There was a significant reduction in least, worst, and average pain in both groups. There were no differences based on group or the combinations of group and time. For both groups, there were significant decreases over time in total doses of opioids taken and no differences between groups in dosage changes. There were no differences between the groups in adjuvant pain medication use or other relevant interventions such as bone-modifying agents.

Conclusions

As used here, the psychoeducational nursing intervention to increase self-care in pain management did not have an impact on pain outcomes. It is not clear if the intervention changed patient behavior in pain management, though both groups in the study had some reduction in pain intensity.

Limitations

  • Risk of bias (no blinding)
  • Subject withdrawals ≥ 10%

Nursing Implications

The psychoeducational intervention used here improved patients’ knowledge about pain management, but it was not clear if it resulted in any behavior change, and there were no differences in pain outcomes between those who received the full intervention and those who were given attention and written instructions for pain control. More evidence is needed to determine the most effective components of this type of intervention. These findings also suggest that the provision of written directions for pain control, daily patient attention via diary use, and simple nursing attention may be as effective as more structured interventions.

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Rustøen, T., Valeberg, B.T., Kolstad, E., Wist, E., Paul, S., & Miaskowski, C. (2012). The Pro-Self© Pain Control Program improves patients' knowledge of cancer pain management. Journal of Pain and Symptom Management, 44, 321–330.

Study Purpose

To evaluate the effects of a psychoeducational intervention on increasing patients’ knowledge and attitudes of cancer pain management

Intervention Characteristics/Basic Study Process

Prior to the intervention, nurses were trained by the PI and study oncologist. The PI listened to audio recordings of the sessions with nurses and patients in the intervention and control groups to ensure fidelity. The Norwegian version of the Pro-Self Pain Control Program intervention was used. A trained oncology nurse made home visits at 1, 3, and 6 weeks and telephone interviews at 2, 4, and 5 weeks. At the week 1 visit, the nurse delivered educational information tailored to each patient’s needs and patients received written instructions about pain and side effect management and were taught how to use a pillbox and how to use a script to help discuss pain management with their physician. At weeks 2, 4, and 5, the intervention group was contacted via phone to review pain score and medication use. The consent of the Pro-Self Pain Control Program was reinforced, and patients received coaching on how to address pain management needs. The same was done for home visits on weeks 3 and 6. The control group was given a booklet about cancer pain management and received home visits and telephone calls on the same schedule as intervention patients. The focus of interaction in the control group was adherence with completing the study diary. Both groups recorded measurements in a pain diary every night.

Sample Characteristics

  • N = 179
  • MEAN AGE = Pro-Self group: 64.32 years (SD = 11.4 years), control group: 67.38 years (SD = 11.4 years)
  • MALES: 47.1% in the Pro-Self group, 55.4% in the control group; FEMALES: 52.9% in the Pro-Self group, 44.6% in the control group
  • KEY DISEASE CHARACTERISTICS: Patients with cancer who had bone metastasis, confirmed radiographically
  • OTHER KEY SAMPLE CHARACTERISTICS: Primary diagnoses include breast, prostate, and colon cancer; 19.5% with other diagnosis; outpatients; able to read, write, and understand; Karnofsky Performance Status (KPS) of 50 or greater; pain intensity score of 2.5 or greater on a 0–10 scale

Setting

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

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • KPS
  • 0–10 pain intensity scale
  • Pain experience scale (PES)
  • Demographic questionnaire
  • Independent student t-tests or chi-squared analysis, mixed-model analysis

Results

At baseline, control patients reported a higher KPS score than those in the intervention group (p = 0.0003). Improvement in all individual and overall (p < 0.001) scores on the PES was noted for patients in the Pro-Self group. A statistically significant improvement was seen in nine items on the PES scale for patients in the intervention group.

Conclusions

The study resulted in an increase in knowledge of cancer pain management in the Pro-Self group.

Limitations

  • Baseline sample/group differences of import: Difference in KPS scores
  • Risk of bias (no blinding)
  • Risk of bias(sample characteristics): Control group had higher KPS score than the Pro-Self group at enrollment, and patients in the Pro-Self group had a lower PES score on one item than the control group
  • Other limitations/explanation: The PES was modified when it was translated into Norwegian, some items on the PES were reverse coded, a drug dependence item on the PES was deleted (because of translational issues), and an item was added because it was included on another pain questionnaire by the American Pain Society’s Quality of Care Committee.

Nursing Implications

Additional research is recommended to examine the influence of the level of education of participants on interventions to improve cancer pain management.  A similar study was completed in the United States using a similar intervention, but the results were not as dramatic (the U.S. study yielded significant improvements in only five of the nine items on the PES, versus significant improvements in all 9 areas in the Norwegian study), which suggests cultural, educational, and demographic influences. Although individualized patient education tends to be more effective, this requires additional time and resources for planning and intervention.

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Ruschulte, H., Franke, M., Gastmeier, P., Zenz, S., Mahr, K.H., Buchholz, S., . . . Piepenbrock, S. (2009). Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: A randomized controlled trial. Annals of Hematology, 88, 267–272. 

Study Purpose

To evaluate the effectiveness of chlorhexidine sponges in prevention of central venous catheter infections inserted for cancer chemotherapy

Intervention Characteristics/Basic Study Process

All patients received chlorhexidine and silver-impregnated, triple-lumen central venous catheters (CVC) that were intended for at least five-day use. Catheter insertion was done using maximal barriers, and skin antisepsis was done with alcohol. Catheter dressings were changed weekly. Patients expected to have catheters in place for less than five days were not included in the study.

Sample Characteristics

  • N = 601   
  • MEDIAN AGE = 47
  • AGE RANGE = 18–73
  • MALES: 55.4%, FEMALES: 44.6%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All had hematological malignancies
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority had CVCs placed in the internal jugular vein

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Germany

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Stated randomized, controlled trial

Measurement Instruments/Methods

  • Diagnosis of central line–associated bloodstream infection (CLABSI) was made based on clinical assessment symptoms of fever, swelling, and/or hypotension for which no other source was identified.

Results

Mean catheter duration was 15.8 days among controls and 16.6 days in the experimental group. Among the treatment group were 19 cases of CVC infection (3.8 per 1,000 catheter days) compared to 34 cases (7 per 1,000 catheter days) in the control group (p = 0.016).

Conclusions

The use of chlorhexidine-impregnated dressings was associated with a lower rate of catheter-related infections.

Limitations

  • Risk of bias (no blinding)
  • Measurement/methods not well described
  • No information on the chemotherapy agents used
  • Unclear definition of catheter-related infection by clinical determination
  • Stated as an RCT, but randomization was not described and usual care not described 
  • Stated that experienced clinician inserted the experimental group catheters, and procedure described
  • Information about insertion or sites for \"control\" group was not described.

Nursing Implications

This study demonstrated supportive evidence for efficacy of chlorhexidine-impregnated dressings in CVC care to reduce the incidence of catheter-related infections. Patients with hematologic cancers receiving chemotherapy as included here are generally at high risk for infection. Interventions that can reduce the risk of infection in this patient population are important to incorporate into practice.

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Rummans, T.A., Clark, M.M., Sloan, J.A., Frost, M.H., Bostwick, J.M., Atherton, P.J., . . . Hanson, J. (2006). Impacting quality of life for patients with advanced cancer with a structured multidisciplinary intervention: A randomized controlled trial. Journal of Clinical Oncology, 24, 635–642.

Intervention Characteristics/Basic Study Process

Intervention consisted of structured sessions, which began with 20 minutes of conditioning exercises conducted by a physical therapist followed by an educational session with cognitive-behavioral strategies for coping with cancer and open discussion with group leaders and other participants. Sessions were balanced with didactic material, a question and answer period, sharing, reflecting, relaxation, and physical activity. Participants attended eight sessions throughout four weeks following enrollment . Intervention was delivered three days per week. After the fourth week, patients filled out quality of life questionnaires, and questionnaires were collected at 8 and 27 weeks after enrollment via mail.

Sample Characteristics

  • N= 103 patients
  • MEAN AGE = 59.6 years
  • AGE RANGE = 31–85 years (85.7% older than 50 years)
  • MALES: 66, FEMALES: 37
  • KEY DISEASE CHARACTERISTICS: Dominant disease status most commonly gastrointestinal (36.7%)
  • OTHER KEY SAMPLE CHARACTERISTICS: 59.2% undergoing current chemo, 77.6% married, 57.1% currently employed
  • INCLUSION CRITERIA: Diagnosed within the past year, an expected survival time of at least six months, and a treatment recommendation of radiation therapy of at least two weeks
  • EXCLUSION CRITERIA: Previous radiation therapy, recurrent disease after a disease-free period longer than six months, psychiatric disorders or active suicidality

Setting

  • LOCATION: Mayo Clinic Rochester

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active treatment

Study Design

  • Randomized, stratified, two-group, controlled clinical trial
    • Structured intervention arm (N = 49)
    • Standard medical care arm (N = 54)

Measurement Instruments/Methods

  • Linear Analogue Self Assessment (LASA)
  • Profile of Mood States (POMS)
  • Spielberger State-Trait Anxiety Inventory (STAI)
  • Symptom Distress Scale (SDS)
  • Functional Assessment of Cancer Therapy (FACT)

Results

Mean score for fatigue scale of the LASA was lower at week four for the intervention group in comparison to the standard care group, but this difference was not significant. No significant differences were observed between groups for the SDS and FACT measures of fatigue at week four. Although intervention may have impact on overall quality of life, no significant effects were observed on fatigue.

Limitations

  • Sample was primarily white and from the Midwest; therefore, results may not be generalizeable.
  • Cost and availability of multidisciplinary team to deliver intervention may limit its application/implementation in areas that are not large academic health centers.
  • Cost was approximately $2,000 per participant for the entire eight-session period. However, costs would be reduced if more individuals participated.
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Ruiz-Tovar, J., Santos, J., Arroyo, A., Llavero, C., Armananzas, L., Lopez-Delgado, A., . . . Calpena, R. (2012). Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. Journal of the American College of Surgeons, 214, 202–207.

Study Purpose

The purpose of the study was to evaluate the effects of peritoneal lavage with normal saline or an antibiotic solution (clindamycin-gentamicin) on intra-abdominal abscesses and wound infection and to determine the microbiologic impact of both irrigations on peritoneal contamination.  

Intervention Characteristics/Basic Study Process

An open surgical approach was used in all patients. The patients were randomized by means of an Internet randomization module into two groups: those undergoing an intra-abdominal lavage with normal saline (group 1) and those first undergoing an intra-abdominal lavage with normal saline followed by a second lavage with a clindamycin-gentamicin solution (group 2). Perioperative systemic antibiotics (ciprofloxacin 400 mg and metronidazole 1,500 mg; single-dose preoperatively, within 30 minutes of incision, and re-dosed after four hours when the surgery is prolonged over that time) were used in both groups. No mechanical bowel preparation took place in any patient.

Sample Characteristics

  • The study had 103 total patients (51 patients in group 1, 52 patients in group 2).  
  • The mean age in group 1 was 68.5 years (SD = 10.2). The mean age in group 2 was 69.9 years (SD = 11.5).
  • For group 1, 62% of participants were male and 38% were female. For group 2, 60% of participants were male and 40% were female.
  • All patients had a diagnosis of adenocarcinoma.
  • Comorbidities included diabetes mellitus (32% of participants in group 1, 29% of participants in group 2), hypertension (48% of participants in group 1, 50% of participants in group 2), dyslipidemia (32% of participants in group 1, 36% of participants in group 2), and cardiomyopathy (24% of participants in group 1, 20% of participants in group 2).
     

Setting

A single-site inpatient setting (the coloproctology unit of the General University Hospital of Elche)
 

Phase of Care and Clinical Applications

 Active treatment

Study Design

Prospective, randomized, placebo-controlled study

Measurement Instruments/Methods

  • Wound infection was measured by the presence of purulent discharge from the surgical wound, confirmed by microbiologic culture, and determined by a wound treatment nurse blinded to the treatment groups.    
  • Intra-abdominal abscess was defined as the presence of a fluid collection on computed tomography (CT) scan in a symptomatic patient, presenting with fever, abdominal pain, prolonged postoperative ileus, or septic stratus. Determined by a radiologist blinded to treatment groups.
     

Results

Wound infection rates were 14% in group 1 and 4% in group 2 (p = 0.009). Intra-abdominal abscess rates were 6% in group 1 and 0% in group 2 (p = 0.014).

In this study, antibiotic lavage was shown to be very effective, reducing the rate of positive culture by 59% after saline lavage to 4% after antibiotic lavage. These data show that, if the peritoneal cavity remains sterile, there is a lower risk of bacteria migrating from the abdominal cavity through the fascia to the subcutaneous tissue. The study also showed reduced intra-abdominal abscess rates.

Conclusions

A lower incidence of infection was noted in patients with antibiotic lavage during contaminated bowel surgery.

Limitations

Findings would not be generalizable to other groups of patients.

Nursing Implications

Findings suggest that antibiotic intra-abdominal lavage may reduce surgical infectious complications in patients undergoing bowel surgery.

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Ruiz Garcia, V., Lopez-Briz, E., Carbonell Sanchis, R., Gonzalvez Perales, J.L., & Bort-Marti, S. (2013). Megestrol acetate for treatment of anorexia-cachexia syndrome. Cochrane Database of Systematic Reviews, 3, CD004310.

Purpose

TYPE OF STUDY:  Meta-analysis and systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews

KEYWORDS: Extensive keyword and specific search term listing per database is provided.

INCLUSION CRITERIA: Studies were included if they were a randomized controlled trial; reported on patients with weight loss and anorexia-cachexia syndrome due to cancer, HIV, or other disease; and studied use of megestrol acetate (MA) compared  to placebo, to active control, or at different doses.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: N = 950 articles

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Quality and risk of bias were evaluated according to the Cochrane handbook criteria.

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED: N (studies) = 35 studies: 23 trials in cancer, with 3,428 patients

KEY SAMPLE CHARACTERISTICS: Patients with lung, gastrointestinal, head and neck, and gynecologic cancer, as well as unspecified cancer types, were included in the studies.

Results

Patients receiving MA had weight gain (RR = 1.55, 95% CI 1.06–2.66) among trials in patients with cancer. Appetite improved with MA in patients with cancer (RR = 2.57, 95% CI 1.48–4.49). In studies where MA was compared to another active drug, such as a steroid or an antidepressant, in patients with cancer, there was no significant advantage with MA in meta-analysis. There was no apparent impact of higher doses of MA on appetite. There were more adverse events with MA than with placebo, with the most common adverse events being edema and thromboembolism. The quality of evidence for findings related to appetite and weight gain were deemed to be very low, mainly due to high risk of bias.

Conclusions

Findings suggest that MA is effective in improving appetite and resulting in weight gain among patients with cancer; however, findings also show that the quality of evidence was very low. MA did not appear to be more effective than other medications such as steroids.

Limitations

The quality of evidence was very low.

Nursing Implications

MA can be effective in improving appetite and weight gain in patients with cancer. Higher doses of MA do not appear to have any greater effect. Nurses should be aware of the possible adverse events associated with MA use, such as thromboembolism. Further research in comparison of risks and benefits of MA in comparison to other medications and strategies to improve appetite and weight gain would be useful.

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Ruhlmann, C.H., Christensen, T.B., Dohn, L.H., Paludan, M., Ronnengart, E., Halekoh, U., . . . Herrstedt, J. (2016). Efficacy and safety of fosaprepitant for the prevention of nausea and emesis during 5 weeks of chemoradiotherapy for cervical cancer (the GAND-emesis study): A multinational, randomised, placebo-controlled, double-blind, phase 3 trial. Lancet Oncology, 17, 509–518. 

Study Purpose

To investigate the efficacy and safety of fosaprepitant in combination with palonosetron and dexamethasone in the prevention of nausea and vomiting during five weeks of fractionated radiotherapy and concomitant weekly cisplatin in patients with cervical cancer

Intervention Characteristics/Basic Study Process

Patients received fractionated radiotherapy and concomitant weekly cisplatin 40 mg/m2 for five weeks. Patients were randomly assigned to receive either single doses of 150 mg fosaprepitant IV or placebo (saline) in combination with 0.25 mg palonosetron IV and 16 mg dexamethasone orally before cisplatin administration. All patients received 8 mg dexamethasone orally twice a day on day 2, 4 mg twice a day on day 3, and 4 mg once a day on day 4. The treatment was repeated for five weeks. Patients kept daily logs of their symptoms, which were reviewed weekly to determine continued eligibility.

Sample Characteristics

  • N = 234   
  • MEAN AGE = 47–48 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Combination radiation and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Cervical cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients who were chemotherapy and radiation therapy naïve, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, who were able to read, understand, and complete questionnaires and daily records in a patient diary throughout the study period
 

 

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Recruited from eight centers in four countries

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Multinational, randomized, double-blind, placebo-controlled, phase-III trial

Measurement Instruments/Methods

  • Functional Living Index-Emesis (FLIE)
  • Common Terminology Criteria for Adverse Events (CTCAE), version 4.02 
  • Pearson X2, modified intention to treat approach
  • Fine and Gray’s proportional subhazard model (competing risk regression)
  • Schoenfeld Residuals Test

Results

Of the patients, 48.7% of the placebo group and 65.7% of the control group with fosaprepitant sustained no emesis at five weeks. A significantly lower cumulative risk of emesis was seen in the fosaprepitant group compared to the placebo group (p + 0.008).

Conclusions

Patients receiving concomitant chemo/radiation therapy for cervical cancer who received fosaprepitant in addition to palonosetron and dexamethasone were less likely to experience emesis and nausea compared to those receiving palonosetron and dexamethasone alone.

Nursing Implications

Neurokinin 1 receptor antagonists (NK1s) use should be considered in the prevention of radiation-induced nausea and vomiting.

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