To determine the effectiveness of ABH gel (containing Ativan^®, Benadryl^®, and Haldol^®) on chemotherapy-induced nausea and vomiting (CINV) in patients with cancer

• N = 22  
• MEAN AGE = 47.1 years (range = 18–72 years)
• MALES: 6 (27.3%), FEMALES: 16 (72.7%)
• KEY DISEASE CHARACTERISTICS: The majority of the enrolled patients were status post–bone marrow transplant and other types of cancer, but the types of cancer were not specified.  
• OTHER KEY SAMPLE CHARACTERISTICS: Twenty patients had Hispanic or Latino background, 16 patients were Caucasian, and six were African American.

• SITE: Single-site    
• SETTING TYPE: Multi-site  
• LOCATION: An outpatient bone marrow transplant clinic and an inpatient palliative care unit at the Virginia Commonwealth University Massey Cancer Center in Richmond, United States

• APPLICATIONS: Palliative care

A randomized, double-blind, placebo-controlled, crossover, noninferiority clinical trail

• The Condensed Memorial Symptom Assessment Scale (CMSAS) was used to assess the symptoms of nausea.

In total, 22 patients enrolled in the study. However, 20 patients completed both arms (treatment and placebo) as a crossover. In the results section, the researcher listed three important findings: the mean change in the nausea score from baseline to 60 minutes post-treatment in both groups was not statistically significant; the ABH gel was not topically absorbed well even four hours after application; and almost 67% of the study patients stated that treatment was not effective in relieving symptoms.

The researchers concluded that the ABH gel in its current formulation should not be used for patients with cancer.

• Small sample (< 30)

The same authors also demonstrated similar results in healthy volunteers in their previously published study in the May 2012 issue of the same journal titled “ABH Gel is not Absorbed From the Skin of Normal Volunteers,” which found that ABH gel is not absorbed well topically. In that study, lorazepam and Haldol^® were almost undetectable in the blood samples of healthy study subjects; in other words, the plasma samples indicated that ABH gel was clinically or therapeutically insignificant. Therefore, ABH gel in its current formulation should not be used in patients with cancer.

To describe the use of methylnaltrexone (MNTX) in pediatric patients with cancer in both inpatient and outpatient settings

A retrospective chart review was conducted on all children, adolescents, and young adults with incurable cancer treated at St. Jude Hospital from May 2008 to June 2013. Pharmacy data and chart data were reviewed for inclusion data. Patients had documented OIC and the administration of enteral preparations and/or suppositories to treat OIC. After standard therapy for OIC was not successful, MNTX was administered subcutaneously at 0.15 mg/kg per dose.

• N = 9  
• AGE RANGE = 17 months-21 years
• MALES: 44%, FEMALES: 56%
• KEY DISEASE CHARACTERISTICS: Progressive, incurable cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Children, adolescent, and young adult

• SITE: Single site  
• SETTING TYPE: Multiple settings    
• LOCATION: Memphis, TN

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Pediatrics and palliative care 

• Retrospective chart review (RCR)

• Data collection tool specific to this study was used.

MNTX administration produced bowel function in seven (78%) of the patients in one hour and with five (71%) of the patients having a response to first dose. With repeated dosing, 71% had continued response. There were no side effects documented. Two patients responded to repeated doses. The drug was effective in four of five patients with intra-abdominal disease.

The study revealed that MNTX can be safe and effective in children, adolescents, and young adults with OIC and end-of-life disease.

• Small sample (less than 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable

OIC is a distressing side effect of opioid pain management. The use of MNTX in pediatric patients with cancer with progressive disease appears to be an effective and safe in this retrospective audit, but prospective randomized clinical trials are required.

• To examine the context of the use of morphine to manage cancer-related pain
• To establish how the views of healthcare professionals, patients, caregivers, and prescribers affect the use of morphine in practice
• To provide a case study and critique of critical interpretive synthesis (CIS) to synthesize a diverse body of evidence

• Databases searched were MEDLINE on OvidSP (1950–2008), CINAHL (1982–2008), EMBASE (1980–2008), PsycINFO (1967–2008), Health Management Information Consortium, and Social Sciences Citation Index accessed via Web of Science (1956–2008).
• Authors designed a search strategy that combined recognized search terms related to morphine (predominantly, terms used by the Cochrane Pain, Palliative and Supportive Care Group for oral morphine for cancer pain) with terms to identify qualitative research. Authors supplemented electronic searching with manual searches and contact with experts.
• Studies were included if they
  • Described results of original qualitative research.
  • Referred to the use of opioids for cancer pain.
  • Were published in English.
• Authors did not cite exclusion criteria.

Electronic searches retrieved a total of 2,886 records. After screening by title, 255 abstracts were retrieved for initial review. Of these the author obtained 30 articles for full review. Reference chaining yielded another 10 articles. A final sample of 19 resources met criteria and were analyzed. The author used a quality-appraisal checklist. Findings from each qualitative report were identified and compared with recommendations regarding effectiveness. Two resources provided the framework of comparison: Cochrane Systematic Review of Oral Morphine for Cancer Pain and the European Association for Palliative Care recommendations regarding use of opioids for cancer pain.

• The sample, across studies, included 465 patients.
• Study samples included male and female patients and self-identified African Americans.
• Samples included caregivers, nurses, patient and caregiver triads, and nursing and medical students. Patients included those who adhered and did not adhere to prescribed regimens, reluctant opioid takers, and older individuals in the community.

The study resulted in the synthesis of four arguments.

• Concerns about opiods:
  • Morphine was the drug of choice.
  • Patients, caregivers, and professionals had deep concerns about starting and continuing morphine therapy. The introduction of morphine was perceived as an accompaniment to worsening disease and death—a last resort.
  • The addictive potential of morphine was a barrier to its use, and anxieties about addiction influenced patients, caregivers, healthcare professionals, and medical and nursing students.
• Opioid use as a balancing act and trade-off:
  • Patients grappled with wanting pain relief while wanting to maintain functionality in their lives. They thought that, if they took opioids to relieve pain, they could experience adverse effects.
  • Adverse effects were viewed as a burden and were either tolerated to achieve relief or avoided by not taking medication.
  • The adverse effect most frequently mentioned was mental clouding and sleepiness.
  • After pain was so severe that taking opioids was the only alternative, the trade-off with side effects became acceptable. This was often when death was imminent. In many cases, patients took the opioids out of concern for others who were witnessing their pain.
• Existential meaning of cancer and cancer pain: Patients identified the meanings that follow.
  • Severe pain negated patients’ will to live.
  • Pain was a reminder of the presence of the cancer.
  • Severe pain indicated worsening disease and impending death.
  • Pain was vicious and exceeded any sense of control.
  • Patients feared that pain would increase before death.
  • Pain was tied up with all the emotions, fears, and uncertainties about the cancer diagnosis.
  • Taking opioids meant the cancer was out of control.
  • Fear of pain with dying was greater than the fear of dying itself.
  • Death would be a release from pain.
  • Cancer pain is a personal and private experience that no one else can understand.
• Intersubjectivity of pain: Cancer pain affects more than just the person experiencing it; it affects health professionals, caregivers, and the patient. Themes in this area follow.
  • Role and influence of health professionals:
    • Fears and concerns about addiction and adverse effects were implicitly or explicitly communicated to patients.
    • Teamwork involving nurses, physicians, patients, and caregivers was crucial to effective pain management.
  • Role of caregivers:
    • Feelings of conflict over how much control to assume in managing analgesia and how much control to give to nurses and the patient.
    • Dose-juggling responsibilities.
    • Despite education, caregivers were skeptical about problems of addiction.
    • They experienced fear, suffering, and helplessness and futility in the setting of unrelieved pain.
  • Management of pain by the patient:
    • Patients described a parallel existence—striving to live while strategizing to have a comfortable death.
    • Use of regular analgesia did not fit with some individuals’ self-image and led to conflict and guilt.
    • Various physical and cognitive strategies to manage pain were used. Most involved input from caregivers. This was a positive benefit for both.

Patients were selective about their disclosure of pain severity. The degree of confidence and trust in providers influenced reporting about pain, treatment choices, and use of opioids. Negative feeling toward providers led to reluctance to report pain.

This review provides a wealth of powerful and meaningful information that healthcare professionals can use to improve how they work with patients and caregivers in the management of cancer-related pain. Findings suggest that many professionals still have concerns about addiction with the use of opioids in the treatment of chronic cancer pain and that these professionals intentionally or unintentionally communicate these concerns, adversely influencing patients' and caregivers' experiences. Findings point to the importance of aggressive management and prevention of adverse side effects from opioids, to have a positive effect on the patient’s sense of the trade-offs involved with opioids. Findings support the concept that a team approach involving providers, caregivers, and patients and trust among team members are crucial to effective pain management.

Nurses can use the themes to guide open discussion and to anticipate potential issues regarding the use of opioids for pain management.

RESOURCE TYPE: Consensus-based guideline

PROCESS OF DEVELOPMENT: Not fully described. Provides only search terms used

Not stated

• Identifies high-risk factors as low neutrophil counts; unrelated or mismatched HCT; a combination of systemic steroid use and low neutrophil counts; high-dose cytarabine, fludarabine, or alemtuzumab; and those with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
• Recommends prophylaxis for patients undergoing allogeneic HCT until at least day 75 or for 16 weeks in patients with graft-versus-host disease
• Recommends mold active prophylaxis for high-risk patients
• Recommends anticandida prophylaxis for low-risk patients
• Provides a review of individual prophylactic medications and application with specific antitumor agents used
• Recommends secondary prophylaxis in those with previous invasive fungal disease

No quality grading of evidence

Provides information regarding risk factors for consideration in determining the specific type of prophylactic agent to be used, and provides comprehensive information regarding metabolism, etc., of individual antifungals.

To explore relationships among variables and evaluate change in symptoms following cognitive behavioral therapy for insomnia (CBTI)

This paper reports a secondary analysis of a randomized controlled trial of CBTI delivered in group sessions over five weeks. Assessments done at baseline and post-treatment were analyzed.

• N = 113     
• MEAN AGE: Intervention group: 65 years, range 55–69; usual care group: 58 years, range 54–66
• MALES: 26%, FEMALES: 74%
• KEY DISEASE CHARACTERISTICS: Had breast, prostate, bowel, or gynecologic cancer and had completed initial therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Had chronic insomnia defined as greater than 30 minutes for delayed sleep onset or wake time after onset, insomnia three or more nights per week for at least three months and scored five or more on the Pittsburgh Sleep Quality Index (PSQI). Most were retired and were not being treated for depression. Average fatigue severity at baseline was 5, anxiety was 7–8, and depression was 4–5.

• SITE: Multi-site   
• SETTING TYPE: Outpatient   
• LOCATION: Scotland

PHASE OF CARE: Transition phase after active treatment

Secondary analysis of a randomized controlled trial

• 10-day sleep diary
• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Symptom Inventory (FSI)

The most common symptom cluster reported was insomnia, anxiety, and fatigue (18% of patients). Clinical-level insomnia was reduced by 52% in the CBTI group compared to a 17.5% reduction in the usual care controls post-intervention (p < .001). CBTI resulted in a 10.9% reduction in rate of clinical levels of fatigue, compared with a 2.5% increase in control patients post-treatment (p = .03). Anxiety rates did not change. Most patients were not clinically depressed at baseline, and no significant differences were seen between groups in depression rates post-intervention.

The CBTI reduced prevalence of insomnia and clinically relevant fatigue.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• At baseline, patients in the intervention group were older; no analysis was shown to determine if this difference was significant. No information is provided regarding medications or other interventions used for sleep or fatigue. Approximately 9% of the sample was lost to follow-up but from which groups is unclear.

Findings support the use of CBTI for sleep/wake disturbance and fatigue management in patients after cancer treatment. Follow-up in this report was immediately after five weeks of the intervention only, so how long-lasting any effects are is not clear.

• FINAL NUMBER STUDIES INCLUDED = 0
• TOTAL PATIENTS INCLUDED IN REVIEW = 134 pediatric patients
• KEY SAMPLE CHARACTERISTICS: A 5HT3 receptor antagonist was used as the antiemetic; age range of 0.5–18 years

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics

Two studies addressed the comparative pediatric evidence related to the selection of a 5HT3 receptor antagonist. One study found a complete control rate of nausea and vomiting of 30% with tropisetron (8 out of 27) and 32% with granisetron (7 out of 22). The other study found a complete control rate of 61% with granisetron (20 out of 33) and 45.5% (15 out of 33) with ondansetron. Three other studies showed improved control of AINV when a corticosteroid was used with a 5HT3 receptor antagonist versus an antiemetic alone in patients receiving highly emetogenic chemotherapy (HEC). Another comparison between the use of IV versus oral 5HT3 receptor antagonists found equivalent effectiveness when used for HEC or moderately emetogenic chemotherapy (MEC).

Because of inconsistencies in the the research studies' methodologies related to pediatric AINC, there were few comparative effectiveness research (CER) examples. The evidence available to support guidelines is of low quality, and many research gaps exist. Barriers related to CER in pediatric AINV include patient factors, discrepancies related to research design, and definitions of complete control, outcomes, and outcome measures.

Insufficient evidence to develop comprehensive guidelines or for CER for AINV control in pediatric patients

Research related to pediatric AINV control is very limited and lacks in quality for comparison. The conclusions ascertained from this article were that children who used a corticosteroid with a 5HT3 receptor antagonist experienced increased efficacy of AINV control, and both IV and oral routes of these drugs have similar efficacy when used with HEC and MEC.

To explore the efficacy and safety of olanzapine in children aged 3–17 years for chemotherapy-induced vomiting (CIV) control

This was a retrospective review of 60 children (158 chemotherapy blocks) who received olanzapine for acute CIV control at institutions in Canada and the United States over a 30-month period. All CIV data were abstracted from the childrens' health records. 

• N = 60  
• MEAN AGE = 13.2 years (range = 3–17 years)
• MALES: 29 (48%), FEMALES: 31 (52%)
• KEY DISEASE CHARACTERISTICS: All children had acute CIV, but diagnoses varied and included osteosarcoma, neuroblastoma, brain tumors, acute lymphoblastic leukemia, rhabdomyosarcoma, and other sarcomas. 
• OTHER KEY SAMPLE CHARACTERISTICS: The median time from cancer diagnosis till the first block of chemotherapy where olanzapine was given was 3.2 months with a range of 0.1–90 months. Children who received oral olanzapine for CIV control and those who received it during the acute phase of the chemotherapy block were eligible. 

• SITE: Multi-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Children’s Medical Center in Dallas, TX; the Hospital for Sick Children at the University of Toronto, Ontario; and the Memorial Sloan Kettering Cancer Center and Children’s Mercy Hospitals and Clinics in Kansas City, MO

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Retrospective chart audit

• The primary outcome was complete response (no CIV).
• Other variables collected from the retrospective audit included age, weight, height, sex, diagnosis, date of diagnosis, antineoplastic and antiemetic medications received, reason for olanzapine, dose and duration, number of vomiting episodes on each day of chemotherapy, liver function tests, reports of drowsiness and dizziness, and other adverse effects from olanzapine.

Sixty children were given olanzapine in 128 blocks of chemotherapy on the first day of chemotherapy (usually highly emetogenic chemotherapy). Children in 125 of the 128 blocks received ondansetron or granisetron, dexamethasone (55%), or aprepitant (18%). Acute-phase CIV control was obtained in 83 (65%) blocks. There was no association between complete response and the olanzapine dose. The most commonly reported side effects were sedation (7%) and increased plasma transaminase concentrations (5%).

Olanzapine may be a useful option for CIV control in pediatric patients. However, the findings from this study were inconclusive regarding clinical efficacy.

• Small sample (< 30)
• Small sample (< 100)
• Other limitations/explanation: The age range was very wide, from 3-year-olds to young adults aged 17 years. They may have responded very differently to medications. The analysis makes it difficult to determine the impact of olanzapine because the other antiemetics that were used varied.

Nurses caring for children with acute CIV should know that olanzapine in a well-monitored situation may be a safe alternative. However, its efficacy was unclear in this study. A prospective study to determine the role of olanzapine alone and in combination with other antiemetics for varied levels of emetogenicity is warranted.

RESOURCE TYPE: Evidence-based guideline

Five thousand nine hundred ninety-three citations were retrieved, and 59 studies were included—13 for breakthrough CINV and 46 for refractory CINV. Very limited evidence in children existed, of which much was weak, as well as evidence regarding the safety and optimal dosages of breakthrough medications, such as metoclopramide and methotrimeprazine, for children.

The review and guideline development process were conducted very well, but limitations include the lack of sufficient evidence for interventions in pediatric patients. Even those recommendations that were presented as strong recommendations were noted to be based on weak evidence.

This guideline provides specific recommendations for alterations in CINV prophylaxis to address breakthrough and refractory CINV in children. It has also exposed research gaps in the areas of efficacy of prophylaxis escalation, optimal dose, efficacy and safety of olanzapine, methotrimeprazine and metoclopramide, optimal palonosetron dose with multiple day chemotherapy, and the extent and clinical significance of interactions between aprepitant and chemotherapy. Safety of metoclopramide in children related to side effects of extrapyramidal symptoms is also questioned.

To compare weekly healing touch to weekly sham therapy on fatigue in women receiving radiation therapy for breast cancer

Participants were randomized to receive either weekly healing touch or weekly sham therapy. Participants were blinded to group assignment. Each session was 45 minutes in length. Participants either wore a neck drape or blindfold so as not to see how the treatment was delivered.

• N = 41  
• MEAN AGE = 51.5 years (SD = 9.2)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: 34 of 41 were Caucasian

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Not identified

• PHASE OF CARE: Active anti-tumor treatment

• Randomized, controlled pilot study

• Brief Fatigue Inventory (BFI)
• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy–Breast (FACT-B)

Depression was positively correlated with fatigue measures. Anxiety was positively associated with fatigue interference. Healing touch participants reported higher levels of fatigue throughout study than control participants. The control group reported greater reduction in fatigue than did the healing touch group.

This pilot study demonstrated that the intervention was feasible. However the study did not demonstrate any benefit in reduction of fatigue in this small sample.

• Small sample (< 100)
• Baseline sample/group differences of import
• Selective outcomes reporting
• Findings not generalizable
• Intervention expensive, impractical, or training needs are required

Healing touch is not harmful to patients, but this small study does not support its use to reduce fatigue in women receiving radiation therapy for breast cancer.

To determine if Biafine was more effective than best supportive care (BSC) in preventing or reducing radiation (RT)-induced dermatitis.

Randomizaton to Biafine versus BSC depended on the institution and included aloe, Aquaphor, other interventions, and no treatment.

Patients were stratified by bra size:  small (32ab, 34ab, 36a), medium (32c, 34c, 36bc, 38abc), or large (all others).

• The sample was comprised of 172 women.
• Median age was 62 years for both groups.
• Patients had breast cancer and were not undergoing chemotherapy.
• Dose was 50 to 59 cGy versus 59 to 64 cGy.

• Dearborn, Michigan
• Philadelphia, Pennsylvania
• White Plains, New York
• Newark, Delaware
• San Francisco, California
• Baltimore, Maryland
• Ann Arbor, Michigan
• Joliet, Illinois
• Albuquerque, New Mexico

The study was a randomized, controlled trial.

• Radiation Therapy Oncology Group (RTOG) toxicity scale weekly and at two and six weeks after RT
• Maximum toxicity was determined to be the worst skin toxicity observed.
• Weekly completion of the Spitzer QOL questionnaire and patient satisfaction

• There was no overall difference in maximum toxicity between the treatment arms during RT.
• No statistical difference was found between arms in the time grade 2 toxicity.
• All had resolution by week 9.
• Large breasted women receiving Biafine were more likely to have no toxicity week 6 after RT (p = 0.002).
• There was an interaction with treatment healing and tobacco use. Smokers in the Biafine arm had 26% no toxicity in follow-up, and smokers in BSC had 57% no toxicity in follow-up (p = 0.06). Those who never smoked and received Biafine had no skin toxicities at 6-week follow-up (p = 0.026).

• Rater bias occurred.
• The authors did not state who rated the patients and what training occurred.
• The authors did not state if patients were checked the same day every week or at the beginning of each patient week.
• The authors did not record what the application technique was and if it was the same across the different institutions.