To study the effectiveness of acupuncture and acupressure in reducing chemotherapy-induced nausea

Patients were treated for one cycle of chemotherapy with acupuncture and acupressure at point P6 and for one cycle at a close sham point. Participants were randomized to acupuncture at P6 or at a close nonacupuncture point, and it was delivered by one of two physicians with training and experience in acupuncture. Participants wore acupressure bands for 72 hours at the same points on both arms and could wear them for an additional four days if needed. The bands were covered with a mull bandage to blind the staff. Participants completed diaries for seven days, documenting intensity (on a 0-6 rating scale), frequency, and duration of nausea and vomiting; additional antiemetics taken; and, on day 7, rate the effectiveness of side effects or impairment by acupuncture or acupressure. Patients completed the Morrow Assessment of Nausea and Emesis (MANE). Oncology staff checked that the diaries were completed accurately, standard antiemetics regimens were followed, and if any adverse reactions related to acupuncture occurred.

• The study consisted of 28 patients receiving moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC).
• Patients were eligible for the study if they
  • Were 18-75 years old.
  • Were scheduled to receive MEC or HEC and standard antiemesis additional medication for rescue predefined for two cycles of chemotherapy.
  • Had a Karnofsky index of 50%.
• Patients were excluded from the study if they had
  • Received chemotherapy within the last three months.
  • Experienced anticipatory nausea and vomiting, cerebral metastasis, chronic ileus or subileus, or lymphedema in arms.
  • Prior knowledge of acupressure points.

The study was conducted by the hematology and gastroenterology departments of a large university hospital in Germany.

This was a randomized, crossover pilot study.

• The MANE, shortened version, was used to measure nausea.
• Patients recorded the Intensity, frequency, and duration of nausea in patient diaries.

• No difference was found between combined acupuncture and acupressure at the P6 point and at the sham point.
• The study was stopped early because of recruitment problems and low incidence of nausea and vomiting in the sham group.
• Half of the participants reported an irradiating feeling, which is a sign of effective acupuncture.

• The sample size was small.
• Incidence of nausea was low in the sham group.
• No acupuncture control group was included.
• No control was included for type of cancer or chemotherapy regimen.
• The sham point may have been too close to P6 or the needle was too deep.

To assess the impact of orally administered prolonged-release (PR) naloxone on the analgesic effectiveness of PR oxycodone and on constipation in patients with severe chronic pain.

The study comprised three phases:

1. Patients entered either a two-week titration or a seven-day run-in period. Patients were individually titrated and stabilized on an oxycodone PR dose of 40, 60, or 80 mg/day.
2. Patients were randomized to four study groups, each comprising a balanced ratio of 40-, 60-, or 80-mg PR oxycodone with placebo or 10- to 40-mg naloxone. Rescue pain medication (up to five 10-mg oxycodone doses per week) was allowed during the maintenance phase.
3. In a two-week open-label phase, patients stopped naloxone therapy and continued PR oxycodone.

• The study reported on a sample of 202 patients aged older than 18 years, with a mean age of 53.8 years.
• The sample comprised 75 men (37.1%) and 127 women (62.9%).
• Only 2.5% of the original 202 screened patients had cancer.
• Most common pain-causing diseases or conditions were back pain (24.3%) and postoperative complications (15.3%).
• Mean duration of pain was 149.3 months.

• Multi-site
• 28 sites in Germany

This was a prospective, placebo-controlled, randomized, double-blind, parallel-group, phase II study.

• Bowel Function Index (BFI)
• Numerical Analog Scale (NAS) for pain assessment

• At week 6, BFI score was statistically significantly different between the 40-mg naloxone and placebo control groups, showing a decrease of severity in bowel dysfunction with naloxone (p = 0.004). 
• At the end of week 8, both 20- and 40-mg naloxone groups had significant differences in BFI scores compared with placebo (p < 0.05).
• No differences existed in mean pain scores between treatment groups at any study time points.
• Titration of participants off of PR oxycodone/naloxone back to single PR oxycodone regimens during the open-label phase resulted in decreased bowel function, and BFI scores returned almost to baseline.
• The incidence of adverse events (AEs), most of which were mild to moderate, was comparable across all treatment groups, although the number of AEs increased along with naloxone dosage.

The study provided evidence that a combination of PR oxycodone/PR naloxone in a 2:1 ratio could enable patients with chronic pain to achieve both adequate pain control and bowel evacuation function.

The study only looked at oxycodone for pain control and did not include many patients with cancer.

An oral combination of PR oxycodone/PR naloxone in a 2:1 ratio seems to improve bowel function without compromising analgesia in patients with chronic pain. Additional study should include patients with cancer and a variety of other opioids.

To evaluate the use of oral naloxone for the management of opiate-associated constipation in patients with cancer.

Patients were observed for six days without intervention. Afterward, oral naloxone was titrated as follows: 3 mg TID (day 1), 6 mg TID (day 2), 9 mg TID (day 3), 12 mg TID (day 4; maximum). Titration was stopped with laxation or increased peristalsis.

• The study reported on a sample of 22 patients.
• The final sample included 17 patients.

Hospital in Germany

This was a controlled study with a control period, but not a control group.

• Himmelsbach Withdrawal Scale was used to monitor possible systemic withdrawal signs such as shivering or piloerection, yawning, perspiration, nausea or vomiting, tremor or restlessness, and lacrimation or rhinorrhea. Each sign was quantified as 0 (none), 1 (mild), 2 (moderate), or 3 (severe).
• Laxation frequency
• Pain intensity on an 11-step numerical rating scale
• Laxatives received
• Ratio of morphine dose to naloxone dose

• Nausea, restlessness, and sweating were the most common side effects.
• Laxation increased in 14 of 17 patients, whereas laxative use decreased in 9 of 17 patients.
• No difference existed in pain rating between study periods.
• Other laxatives used were lactulose, paraffin, raglan, glycerol, castor oil, and sodium picosulfate.
• Naloxone dose was based on opioid-tolerance level rather than morphine dose.

Starting with a low dose of naloxone and titrating up is recommended.

• Only six days were allocated for measurement periods.
• A subjective Likert-type scale from 0 to 3 was used.
• No control group existed for other laxative use (all participants were on at least one).
• Overdosed patients (via medication error) were kept on the study.
• The study did not control for diet, exercise, and fluid intake.
• The p-value was not tested.

Medical information was collected from a computer database. Patients received either DMPA or D- tryptophan -6-leutenizng hormone-releasing hormone agonist (GnRH-a) or no treatment before myelosuppressive chemotherapy.

 

• N = 101 (42 received DMPA, 39 received GnRH-a, 20 remained untreated)
• MEAN AGE = 29.8 years
• OTHER KEY SAMPLE CHARACTERISTICS: 93 had BMT, and eight had non-ablative regimens. Only patients who developed thrombocytopenia less than 25k were included in the study. Patients had confirmed ovarian function. Patients were excluded who were receiving hormonal therapy, including oral contraceptives, immediately prior to therapy.
   

• Retrospective clinical study

• Severe thrombocytopenia = platelets less than 25K
• Number of days of thrombocytopenia
• Number of blood units required
• ANOVA—if ANOVA 0.05 level paired comparisons with Mann-Whitney
• Multiple comparisons with Student-Newman-Keuls
• General bleeding, amount of bleeding, and number of gynecologic visits tested with chi-square
• Nonvaginal bleeding (1 = no bleeding, 2 = mild—mucosal bleeding or skin hemm, 3 = moderate bleeding—bleeding from major organ system, 4 = severe—life threatening)
• Vaginal bleeding (1 = none, 2 = spotting mild, 3 = moderate—daily blood loss comparable to regular menses but requiring intervention because of duration, 4 = significant, requiring intervention)

Four patients were excluded because of gynecologic pathology. Average days of thrombocytopenia was 24.75 +/- 23.6 days. There was no statistical significant difference between groups regarding duration of thrombocytopenia. There was no difference in moderate to severe nonvaginal bleeding. There was no difference in platelet /packed red blood cells and fresh frozen plasma transfusions. Moderate/severe vaginal bleeding occurred in 16.8%—both treatment groups had lower rates of menorrhagia than untreated groups. None of the GnRH-a group had moderate/severe vaginal bleeding (p-0.002). There was a need for urgent gynecologic consult—untreated versus treated (P < 0.0001). Urgent treatment with estrogen was needed in the DMPA group but not the GnRh-a group (P = 0.004).

 
 

To compare the use of medical clowning with the use of local anesthetic cream or the use of no intervention on pain in children undergoing a procedure

The study authors evaluated the use of a trained medical clown with the application of an anesthetic cream or no intervention on the effect on children’s pain and anxiety associated with a procedure. The control group underwent a blood draw/venipuncture without any intervention. The medical clown group had the clown distract and entertain the child from 10 minutes before as well as during and after the procedure. The final group had children given a local anesthetic containing a mixture of lidocaine and prilocaine 50 minutes prior to the blood draw/venipuncture. Duration of crying was measured by an independent observer, pain level was assessed by the child using the visual analog scale (VAS) for pain, and pain and anxiety were also assessed from the parents' perspective using VAS for pain and anxiety during a follow-up phone call.

• N = 100   
• AGE = 2–10 years
• MALES: 53%, FEMALES: 47%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: Unknown

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Carmel Medical Center

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Pediatrics

• Randomized, controlled trial

• Visual analog score (VAS) for pain ratings by children and parents, similar VAS for anxiety rated by parents
• Observation of duration of crying by an independent trained observer
• Wong-Baker FACES Pain Rating scale used for the children

The duration of the child crying was significantly shorter with the clown group than in the control group (p = 0.01). The duration of crying prior to the procedure was significantly shorter in the clown group compared to the EMLA cream group (p < 0.05) and control group (p < 0.01). The child’s assessment of pain was significantly less in the EMLA group compared to the control group (p = 0.04), but no difference existed between the clown and control groups. The parent’s assessment of the child’s pain was lowest in the clown group (p < 0.05 between all groups). Parent’s assessment of future anxiety was significantly lower in the clown group than the EMLA group or control group (p < 0.05).

The use of the medical clown had a positive effect on parents’ anxiety for future venipuncture as well as anticipatory crying duration and perception of pain in children.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Possible differences in children’s diagnoses and reason for venipuncture

Nurses should be aware of alternative methods such as the use of a medical clown for distracting or controlling children’s pain. Although medicine is shown to have a significant effect on the child’s pain, these methods can assist with both children and parents’ anxiety and management of pain.

To compare the effectiveness of dronabinol alone or in combination with ondansetron versus ondansetron alone for delayed, chemotherapy-induced nausea and vomiting (CINV) among patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in multiple cancer centers

• The study took place over five days.
• Participants were randomized to four treatment groups: dronabinol alone, ondansetron alone, combination with both drugs, and placebo. 
• Standard pretreatment medications, fixed doses on day 2, and flexible doses days 3-5 were administered.
• Participants were assessed based on patient telephone diary entries. Each morning, patients reported symptoms from the previous day via the Interactive Voice Response System.

• The study consisted of 64 participants, aged 18 years or older, with a malignancy that did not involve bone marrow.
• Participants were undergoing chemotherapy regimens and had performance statuses of 0–2 at screening. They could be receiving concurrent radiation except to the abdomen and changing regimens with last antiemetics seven days prior to study enrollment.
• For women, a negative pregnancy test at baseline was required.
• Diagnoses involved primary malignancy of the brain, spinal cord, or nervous system; brain metastases; severe brain trauma or surgery; leukemias; or lymphomas.
• Patients who had used marijuana within 30 days or antiemetics within 7 days were excluded from the study.

The study was conducted at multiple cancer centers.

This was a randomized, double-blind, placebo-controlled, parallel-group study.

The following measurement instruments were used.

• Visual analog scale (VAS)
• Total response
• Intensity of nausea
• Eastern Cooperative Oncology Group (ECOG) performance status
• McCorkle Symptom Distress Scale

Difficulties in enrollment led to early termination of this study.

• The efficacy of dronabinol alone was comparable with ondansetron for the treatment of delayed CINV in patients with cancer receiving HEC or MEC.
• Combination therapy with dronabinol and ondansetron was not more effective than either agent alone.

• Patients had difficulties with potential for randomization to placebo when receiving HEC or MEC.
• Early discontinuation of the study reduced the number of participants enrolled in each treatment group.
• The population was heterogeneous.
• No control chemotherapy treatment was used.
• The majority of patients had breast or lung cancer.

To evaluate, by means of a systematic review, whether evidence supports systematic screening for depression as part of cancer care

• Databases searched were CINAHL, Cochrane Database, EMBASE, Institute of Science Index (ISI), MEDLINE, PsycINFO, Scopus, Google Scholar, Clinical Trials.gov, International Standard Randomised Control Trial Number Register
• Authors did not specify search keywords.
• Studies were included if they compared a depression-screening instrument to a valid criterion for major depressive disorder (MDD), they were randomized clinical trials (RCTs) that compared depression treatment with placebo or usual care, or they were an RCT that  assessed the effect of screening on depression outcomes. Eligible articles included studies in any language on cancer patients with any type of malignancy at any disease stage that reported original data.
• Studies were excluded if they were part of a case series or were case reports.

• Investigators retrieved a total of 2,302 studies.
• Two investigators independently reviewed articles. Consensus resolved discrepancies.
• Investigators asked three questions: What was the accuracy of the depression-screening instruments? Does treatment of depression improve depression symptoms? Is depression screening more effective than usual care in reducing depression symptoms? Specific inclusion criteria varied according to question. Studies reporting on the same sample were considered one study. Results were broken down by question.    
   

• The final number of studies included in analysis was 20.
• For question 1, the median sample size was 128; for question 2, 200; for question 3, 0. The sample range across samples was, for question 1, 16–381; for question 2, 200; for question 3, 0.
• The sample included 8 studies of breast cancer and 11 with a mixed-cancer diagnosis.
• Mean patient age was 57 years.
• Overall, 30% of participants were male and 70% were female.

• In regard to question 1: Six studies measured depression by means of the Hospital Anxiety and Depression Scale (HADS), using a cutoff of 15–20. Nine studies employed the HADS Depression Subscale, using a cutoff of 5–11. Three studies had predefined cutoff scores. HADS was the only screening tool used in more than one study. Seventeen of 19 studies did not exclude patients with current depression treatment or diagnosis.
• In regard to question 2: One RCT compared usual care versus a nurse-delivered collaborative care intervention. The trial comprised 10 one-to-one sessions over three months (the mean number of sessions completed was seven). Postintervention scores were lower in the treatment group than the scores in the usual-care group.
• In regard to question 3: No studies were eligible for analysis.
• In a high-quality RCT, a nurse-led collaborative intervention to facilitate depression care improved depression outcomes more than did usual care.

Data from this analysis do not support the hypothesis that screening for depression improves depression-related outcomes.

More work is needed to determine how screening directly or indirectly affects depression-related outcomes. All patients should have access to depression care from a multidisciplinary team.

To investigate whether an exercise intervention reduces anxiety and depression, and improves quality of life, body image, and physical fitness in women with breast cancer

Patients were randomly assigned to the intervention or a wait list control group after a sports medicine assessment. The intervention group received structured group exercise training twice weekly for 10 weeks. Training sessions lasted 90 minutes, were done in small groups (five patients), and included two main components: (a) warm-up, dance and movement games, physiotherapeutic exercises, and relaxation, and (b) moderate walking and jogging outdoors. Patients wore heart monitors during exercise. Sessions were led by a physio- or sports medicine therapist. Outcome variables were measured at baseline and at the end of the 10-week study period.

• The study initially had 63 enrolled participants; 11 completed the 10-week program.
• Mean participant age was 51.88 ± 8.46.
• All participants were females diagnosed with breast cancer; 51.7% had stage I disease.
• Of the sample, 58.9% had breast-conserving surgery, 34.5% had lymphedema, and 1.8% had no surgery. All were entered after at least four weeks post-adjuvant treatment.
• Half of the sample did regular sports and fitness activities as part of their usual lifestyle, 77.2% were either married or in a relationship, and 26.4% had a college education.

• Single site
• Outpatient setting
• Germany

• Patients were undergoing the transition phase of care after initial treatment.
• The study has clinical applicability for late effects and survivorship.

A randomized controlled trial design was used.

• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
• Short-Form Health Survey–36 (SF-36)–German version
• Body Image Questionnaire
• Symptom Checklist–90–revised (symptom burden measure)

Anxiety declined over time in all patients (p = 0.08), and ANOVA showed a significant interaction of the intervention (p = 0.03). The effect size in anxiety with the intervention was -0.54 (95% CI -1.06 to -0.02). Depression declined over time in all patients (p = 0.02), but there was no interaction effect with the intervention. Body image improved over time in all patients (p = 0.003), and there was a significant interaction effect of group assignment (p = 0.006); however, body image at baseline was also better in the intervention group. There were no differences between groups in symptom burden or quality of life.

Participation in this exercise intervention was associated with a significant decline in anxiety.

• The study did not include an appropriate control group.
• The study had no attentional control.
• The final group of patients who completed the intervention and were analyzed was very small, only 11 patients.
• Authors reported different sample sizes in different tables and figures, suggesting the potential for issues in data analysis, and there is no discussion of reasons for missing data.
• Authors stated that the intervention was effective for depression, although the ANOVA did not demonstrate a significant group and time interaction effect on this variable, suggesting some investigator bias in discussion of results.
• Authors stated an intervention adherence rate of about 50%, but there was actually a 63% drop-out rate.

Study findings suggest that group exercise can be helpful in reducing anxiety in patients with breast cancer after completion of adjuvant treatment. These study results should be interpreted with caution given the high drop-out rate and study limitations.

To evaluate the efficacy of 1% hydrocortisone cream for the prevention of acute radiodermatitis

Patients were randomized to receive either 1% hydrocortisone or placebo cream. Patients were to apply the cream to the irradiated field twice daily beginning on the first day of radiation therapy until one week after the last radiation session. The cream was to be applied at least two hours prior to therapy. Patients were instructed not to use any other topical medications or deodorants during the study. In case of severe radiodermatitis, additional treatment was determined by the dermatologist. These patients were considered treatment failures and were included in the analysis. Patients were evaluated at one, two, three, four, and five weeks.

• N = 50
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer after modified radical mastectomy who had completed chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: The radiation dose was 50 Gy in 25 fractions five times weekly to the chest wall, surgical scar, and regional lymph nodes using a Cobalt 60 machine.

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

PHASE OF CARE: Active antitumor treatment

• Double-blind, placebo-controlled, randomized, controlled trial

• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0
• Visual analog scale (VAS) for pruritus, burning, and pain
• Dermatology Life Quality Index (DLQI)

Four patients from each group developed moist desquamation by week 5. No difference existed between groups in preventing moist desquamation. At week 1, a higher incidence of grade 1 dermatitis was observed in the placebo group (p = 0.038), and at week 4, a higher occurrence of grade 2 dermatitis was observed in the placebo group (p = 0.017). Groups were comparable at weeks 3–5. The incidence of pruritus was less in the steroid group in weeks 4 and 5 (p < 0.04).

The findings suggest that the use of topical 1% hydrocortisone cream reduced pruritus and delayed the onset of radiation dermatitis. However, it did not prevent moist desquamation compared to the placebo.

• Key sample group differences that could influence results
• Significant differences were observed between groups in total field size irradiated.
• No information on differences between groups in breast size or skin folds in the field was provided.
• Use of Cobalt 60 versus IMRT

Topical steroid cream was associated with less pruritus from radiodermatitis and may delay the onset of skin problems; however, it was not effective in preventing severe skin toxicity. Whether stronger formulations would be more beneficial is unclear. Patients can benefit from the use of topical steroids to reduce itching.

 To evaluate the effectiveness of a zinc-containing mouthwash on chemotherapy-induced oral mucositis in comparison with chlorhexidine gluconate mouthwash as control.

Patients with acute myeloid leukemia under chemotherapy were allocated to an experimental and control groups of 15 patients each. The required dilution of 0.2% zinc sulphate and chlorhexidine gluconate mouthwashes. Subjects instructed to rinse with 10 ml of 0.2% zinc sulphate mouthwash twice a day for 14 days in the experimental group. The control group used 0.2% chlorhexidine mouthwash in the same manner. The mouthwashes were coded with A and B letters on the bottles, and the investigator, as well as the subjects were blinded to the type of the mouthwash, which was administered to the groups by a simple random method. All subjects were examined every other week for eight weeks.

The study was comprised of 30 patients, over 15 years of age.

MALES (%) Not specified, FEMALES (%) Not specified

KEY DISEASE CHARACTERISTICS: Acute myeloid leukemia

OTHER KEY SAMPLE CHARACTERISTICS: Subjects receiving an established treatment plan of Cytarabine in the induction phase and Novantrone in the consolidation phase were included in the study. Exclusion criteria included no subject <15 years of age. Allergy to zinc or chlorhexidine mouthwashes. Any systemic disease with other diagnosis of malignancies or chemotherapy-induced oral mucositis, any oral ulcers, or mucositis developed before starting chemotherapy.
 

SITE: Single site

LOCATION: The oncology ward of Shahid Gazi Hospital in Tabriz, Iran

PHASE OF CARE: Active treatment

APPLICATIONS: Acute myeloid leukemia

Randomized, double-blind, controlled

• Instrument: Spijkervet Scale was used to grade the severity of Mucositis    
• Observation: The efficacy of the treatment at each session was determined by recording the length (E) of the lesion, measured by a digital caliper, and its severity (K), based on local signs.
• Observation: Eight distinguishable irradiated areas of the mouth including buccal mucosa (left and right), soft and hard palate, dorsum and border of the tongue (left and right), and the floor were evaluated.
• Observation: The score of each area was defined as the product of the length and severity score from the Spijkervet Scale. The mucositis score (alpha) in each individual was defined as the mean of the scores assigned to the evaluated areas, and ranged from 0-16.
• Observation: Independent t-test used for evaluation of any probability of differences between the groups in regard to baseline.
   

There were no significant differences between the case and control groups in the first week (p = 0.124). The trends of changes in the assessed oral mucositis index during the course of the study were similar in both groups. The mean a (alpha) index in both groups increased from the first week to the third week and then decreased in the fourth week. Although the mean a (alpha) index was generally lower in the test group compared to the control  group at all four time intervals evaluated, repeated measure ANOVA revealed that the difference was statistically significant in weeks 2 and 3 (p = 0.025).

 Zinc mouthwash used in conjunction with chemotherapy may reduce the severity of oral mucositis lesions in patients with leukemia.

•  Small sample <100
•  Lack of  ability to generalize. Lack of the prophylactic agent (zinc) at different concentrations.  
   

The double-blind study is the most efficacious. Within the field of oncology, the occurrence of mucositis has always been associated as a side effect of chemo-radiation therapies. Mucositis is a result of radiotherapy and chemotherapy or a combination of the two. Thus, mucositis needs immediate and timely nursing interventions. The zinc mouthwash appears to be cost effective and easy to use. To this, clinical trials with randomized testing within the United States that support zinc mouthwash may be beneficial. Nurses who are in the oncology setting face challenges to plan and provide care that promotes the best possible health related outcomes for their patients.