To investigate the safety and efficacy of single-dose palliative chest reirradiation for pain control

Patients who had been treated with three-dimensional conformal radiation therapy (RT) and concurrent cisplatin-based therapy were given reirradiation to the chest area previously included in the > 90% prescribed dose region. Pain management was evaluated according to the World Health Organization step ladder.

• N = 78  
• MEDIAN AGE = 67.3 years (range = 37–88 years)
• MALES: 70.5%, FEMALES: 29.5%
• KEY DISEASE CHARACTERISTICS: 76% of participants had local tumor recurrence.

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

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care 

Retrospective, descriptive study

• 10-point Visual Analog Scale (VAS) for pain
• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0
• Response evaluation criteria in solid tumors

There were no radiation-associated toxicities greater than grade 2. The median VAS score before reirradiation was 7 (range = 4–9), and the median score after reirradiation was 3 (range = 0–8, p < 0.001). Thoracic disease was stabilized in 33.3% of patients and partially regressed in 21.1%. No factors predicting better pain responses were identified.

Reirradiation to the chest area was effective for most patients in reducing pain associated with non-small cell lung cancer. It was not associated with severe adverse effects. Two patients developed esophagitis, and three developed pneumonitis. The median time to the lowest pain score was 27 days, and the mean duration of relief was 6.1 months.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: This study had a retrospective design. The timing of VAS measurements was not mentioned. No information about other interventions for pain relief or medication alterations within the duration of study observations was recorded.

Locoregional failures at the margins of previous RT fields can be associated with severe pain in patients with lung cancer. This study suggested that single-dose reirradiation may reduce pain.

• Patients received 150 mcg octreotide subcutaneously three times daily once they were unresponsive to oral loperamide administration (4 mg three times per day for 48 hours).
• All patients received hydration and were advised to consume a low-fiber, low-lactose diet.

• The study reported on 42 patients with rectal carcinoma who experienced grade 2-3 diarrhea associated with at least one course of 5-fluorouracil (5-FU) administration refractory to loperamide during whole pelvic radiation therapy (RT).
• The maximum number of days of octreotide treatment was five. If patients had progressive improvement of chemoradiotherapy-induced diarrhea (CRTID) during the five days of treatment but not a complete response (CR), chemoradiotherapy (CRT) was discontinued and octreotide was extended for three days.

This study was prospectively designed.

The primary goal was complete resolution of CRTID. The secondary goal was prevention of treatment delays attributed to diarrhea.

• The median duration of diarrhea prior to first dose of octreotide was 78 hours.
• Most cases of diarrhea were diagnosed in the first four weeks.
• The median time-to-first dose of octreotide acetate was 19 days.
• All patients tolerated octreotide well.
• Complete resolution of diarrhea was achieved in 34 of 42 patients during the planned treatment period (five days).
• Average time to CR was 2.7 days.
• No treatment delays were reported in 34 patients who responded to subcutaneous octreotide administration.
• CRT was delayed an average of 7.7 days in the eight unresponsive patients.
• Those with CR were able to be treated as outpatients; nonresponders required hospitalization.

• The sample size was small.
• The study looked at rectal carcinoma only so generalizing to other disease sites is difficult.
• No statistical significance was reported.
• Only descriptive results were provided.

In the original protocol, infliximab was given as an intravenous infusion at 5 mg/kg over a two-hour period, followed by a two-hour observation period, at baseline and two, four, and every four weeks after that if improvement was demonstrated. After a patient suffered a serious infection following the week 2 infusion, the dosing regimen was amended to 5 mg/kg at week 0 and every four weeks after if improvement was observed. The first five patients were treated under the original protocol, and the next 12 were treated according to the amended protocol. Patient outcomes were evaluated at every time point.

• The sample was comprised of 17 patients with end-stage cancer.
• Mean age was 63.5 years.
• The majority of the patients were male (76.5%) and had multiple cancer diagnoses, with the most common being renal cell carcinoma (23.5%) and nonsmall cell lung carcinoma (NSCLC) (23.5%).
• Patients were excluded if they had a reversible cause of fatigue (i.e., anemia, hypercalcemia, hyponatremia, or hypothyroidism) or had major surgery, chemotherapy, or radiotherapy within four weeks of study enrollment, which were medical contraindications for infliximab treatment.

Outpatient, daytime therapy clinics for specialist palliative care at the Marie Curie Hospice, United Kingdom

Patients were undergoing the palliative phase of care.

This was an open-label, pilot study.

Fatigue Severity Scale (FSS)

The infliximab intervention did not show an overall improvement of fatigue in patients. However, a small cohort of six patients showed an improvement in FSS scores over time with repeated infliximab infusions, although this difference did not reach statistical significance. The six patients shared a similar profile of NSCLC that was progressive through chemotherapy and received the amended protocol treatment.

• The study had a small sample size.
• The stuck lacked a neutral comparison group.

• FINAL NUMBER STUDIES INCLUDED = 72
• TOTAL PATIENTS INCLUDED IN REVIEW = 5,367 (2,740 in intervention, 2,627 control groups)
• KEY SAMPLE CHARACTERISTICS: 19% aerobic, 26% walking, 12.5% yoga, 31% mixed-exercise, 63% supervised, 36% home-based, 63% mixed malignancy, 26% solid tumor, 11% hematologic; and most patients off treatment

PHASE OF CARE: Multiple phases of care

There was a moderate effect on fatigue, sleep disturbance, and depression with exercise in the intervention groups (p < 0.001) compared to the control group. The benefits of exercise did not differ by type of exercise intervention (P = 0.85 for interaction). However, the effect of exercise on fatigue reduction may differ by underlying malignancy type with a stronger effect in solid tumors versus hematologic and mixed-malignancy types (P = 0.01 for interaction). There was a stronger effect on depression in females (p = 0.03). Patients with solid tumors seemed to experience a greater benefit.

Exercise can have an effect on fatigue despite the type of exercise and phase of care when delivered.

The clinical effect of what is considered a significant reduction in Functional Assessment of Cancer Therapy - Fatigue was questioned. The terms physical activity and exercise were used interchangeably, and the meaning of structured exercise was not well-explained.

Patients may be given several options for kinds of exercise to improve fatigue based on their preference while still receiving the benefit of improved fatigue.

To evaluate the effect of different doses of oral suspension of megestrol acetate (MA) on appetite, quality of life, body weight, and anthropometric measures in patients with advanced cancer

Researchers evaluated a fixed dose of MA (480 mg) versus escalating doses of MA. Patients were evaluated at baseline, two, four, and eight weeks.

• The study included 22 patients with advanced, nonhormonally dependent cancer who were experiencing anorexia-related weight loss (at least 5% of usual body weight).
• Patients had a life expectancy of more than three months, and a World Health Organization performance status of two or less.
• Median patient age was 59 years.
• A total of 19 patients were evaluated (2 died, 1 withdrew): 15 men and 4 women.
• Patients were diagnosed with lung cancer (nine), gastrointestinal cancer (six), renal cancer (two), mesothelioma (one), and non-Hodgkin lymphoma (one).
• At eight weeks, 12 patients were evaluated (eight patients died, one withdrew from study, and one stopped because of side effects).

The study was a randomized, multicenter, blinded, two-arm trial.

• Visual analog scale using 0–100 mm to measure appetite (patient self-report)
• Body weight
• Anthropometric measures of mid-arm circumference and four skinfold thickness
• Hand grip strength
• Serum measure of albumin, prealbumin, c-reactive protein, and cortisol
• European Organization for Research and Treatment Cancer Core Quality of Life questionnaire (EORTC QLQ-C30, version 1.0)

Twelve patients were evaluated at eight weeks (eight patients died, one withdrew from study, and one stopped because of side effects). Therefore, the patients were evaluated as a single group regardless of whether they were receiving a fixed dose or an escalating dose of MA. There was statistically significant improvement in appetite over baseline in all patients at two weeks (p = 0.0001), four weeks (p = < 0.01), and eight weeks (p = 0.022). Overall quality of life improved in the majority of patients at two and eight weeks, but it was not statistically significant. There was no statistically significant improvement in body weight or other measures. In terms of side effects, 4 of 19 patients experienced clinically significant edema, resulting in 1 patient withdrawing from the study.

Original aims of the study could not be met because of the small sample size, so no conclusions can be drawn about the effectiveness of oral MA suspension or optimal or superior dose of MA.

• The study had a very small sample size, with significant attrition (36%).
• The study had no placebo group; all patients were assessed compared to their baseline measures.

STUDY PURPOSE: To review published trials of hypnotic treatments for children with chronic and cancer-related pain

TYPE OF STUDY: Systematic review

DATABASES USED: MEDLINE, PsycINFO, Cochrane Collaboration

KEYWORDS: Children, hypnosis, pain

INCLUSION CRITERIA: RCT; patients 18 years old or younger; Catalan, English, French, Portuguese, or Spanish languages; included patients with chronic pain or cancer procedure-related pain

EXCLUSION CRITERIA: Abstracts only, not published in full in peer-reviewed journals

TOTAL REFERENCES RETRIEVED: 81

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: No study quality evaluation reported

• FINAL NUMBER STUDIES INCLUDED = 12 (10 in cancer)
• SAMPLE RANGE ACROSS STUDIES: 20–80
• TOTAL PATIENTS INCLUDED IN REVIEW: Total in cancer studies = 394
• KEY SAMPLE CHARACTERISTICS: Procedures involved were bone marrow aspiration, LP, or venipuncture

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Pediatrics

All studies in children with cancer were related to acute procedure-related pain and anxiety. Hypnotic interventions were better at reducing pain than no treatment, standard care, placebo, and attention control. Compared to other psychological treatments, hypnosis had about the same effectiveness as cognitive behavioral therapy. Comparison of hypnosis to distraction showed mixed results. Younger patients had significantly better responses to hypnosis. Parents of those receiving hypnosis had lower anxiety. Results of hypnosis on anxiety were mixed. One study showed similar effects between hypnosis and play. Calculated effect sizes with hypnosis showed decrease in pain of 20%–80%. In four studies that included follow up at 3–12 months, therapeutic effects appeared to be long-lasting.

Hypnosis is effective in reducing acute procedure-related pain among children with cancer.

Studies tended to have small samples, and many of these studies were done by the same group of researchers.

Findings of this systematic review support the use of hypnosis in children undergoing invasive procedures for reduction in pain. Nurses can advocate for availability of this intervention in pediatric settings.

To update previously published guidelines from 2000 for the prevention of infection in patients receiving any type of hematopoietic stem cell transplantation (HSCT). Patients analyzed were adults and pediatric populations receiving allogeneic or autologous HSCT.

The resource was presented as an evidence-based guideline. An international group of experts from identified professional organizations reviewed and graded evidence and developed recommendations.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for pediatric populations.

The volume and highly specific process were not discussed.

Recommendations were made, and possible opportunistic infections at pre-engraftment, post-engraftment, and late phases of HSCT were identified. Recommendations included

• Antibiotic and antifungal prophylaxis.
• Consideration of hepatitis B vaccination for those who are hepatitis B-naïve and for donors and recipients of allogeneic transplantation prior to cell collection.
• Varicella-zoster virus (VZV) vaccination for people in close contact and healthcare providers who are seronegative at least six weeks prior to HSCT contact.
• Measles, mumps, rubella (MMR) vaccination of those in close contact and healthcare workers.
• MMR patient vaccination for select groups of patients.
• Policies that prohibit visits or close contact for people with respiratory or flu-like symptoms.
• Education to reduce exposure to potential opportunistic infections.
• Pneumococcal vaccination, annual influenza vaccination, hepatitis B vaccination, consideration of hepatitis A vaccination for people in areas where hepatitis A is endemic, diphtheria vaccination for appropriate age children according to general immunization guidelines, and pertussis reimmunization of appropriate patients.

Timing and appropriate individuals for various immunizations are important considerations, and it is recommended that users of this information refer to the full report. Overall, use of live vaccines is contraindicated for these patients; vaccination is contraindicated in those with chronic graft-versus-host disease or when patients are still immunosuppressed.

Some recommendations were based on expert opinion due to lack of research evidence in the area.

Specific interventions for prevention of infection among HSCT recipients is a complex field, and healthcare providers who work with these patients need to be aware of current knowledge. Evidence in this area continues to evolve as HSCT techniques change and further evidence is gained regarding the immediate and long-term effects of HSCT.

To assess the efficacy of propolis versus placebo for the treatment of chemotherapy-induced severe oral mucositis (OM) treatment as a complementary and alternative medicine to alleviate severe OM from cancer therapy in the pediatric population. Propolis is a resinous material collected by bees from various plant sources and mixed with the bee’s salivary enzymes and beeswax. Recent scientific evidence suggests that honeybee products include anti-inflammatory, antioxidant, and antimicrobial properties.

The pediatric patients randomly were assigned to two groups: propolis or placebo. The oral care protocol consisted of teeth brushing.

The propolis or placebo was applied twice a day—once in the morning and once in the evening. The patients' OM was assessed according to the modified Eilers Oral Assessment Guide (OAG) twice a week when the patients were in the hospital. Patients were followed for the period of the chemotherapy or the first six months of the chemotherapy. An average of 0.38 g of propolis or placebo was used for each application. Each patient was given an information folder to reinforce cooperation and help them remember the protocol. A protocol follow-up regarding side effects and efficacy was assessed by questionnaire.

• N = 40
• AGE = 1–19 years
• MALES: 20 (50%), FEMALES: 20 (50%)
• KEY DISEASE CHARACTERISTICS: Variety of children’s cancer, no specific diagnosis given

• SITE: Single site 
• SETTING TYPE: Inpatient    
• LOCATION: Division of Oncology and Haematology, University Children’s Hospital, Medical Centre, Ljubljana

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

• Double-blind, randomized, placebo-controlled study

OM was clinically assessed using a dental mirror and portable head light. OM was scored according to the modified Eilers OAG twice a week.

The study assessed OM episode frequency, duration, and severity. The OM episode frequency and OM mean duration were assessed. The frequency of severe OM and duration of OM were not statistically significant between the study groups. Thus, the findings found that severe OM was of slightly shorter duration and of a lesser extent in the propolis group. The study results demonstrated that almost half of the patients enrolled in the study suffered from severe OM. Severe OM was seen in 18 (45%) patients. In the propolis group, 8 of 19 (42%) patients had OM, while in the placebo group, the corresponding number was 10 of 21 (48%). Twenty-four episodes of severe OM were recorded—10 (42%) in the propolis group and 14 (58%) in the placebo group.

The authors do not recommend propolis in severe OM as a treatment plan. Because of the limitations in the study design, further clinical studies are needed to verify whether the use of propolis in OM treatment truly is not justified.

• Small sample (< 30)
• Baseline sample/group differences of import
• Measurement validity/reliability questionable
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Small sample size (50 patients and dropped 10 [20%]), key sample group differences that could influence results (the type of cancer might be important), measurement was discussed and appropriate but did not include validity/reliability of instrument used, the findings are not generalizable, less than optimal preparation of the propolis

The study was limited to the pediatric population in one hospital. Therefore, there is a need to replicate it with a different study population and multiple settings to establish regular use and guidelines.

To explore the anti-inflammatory and radiodermatitis prevention efficacy and safety of a Boswellia-based topical cream among patients with breast cancer

• N = 114  
• MEAN AGE = 58.5 years (32–78)
• MALES (%): Not stated, FEMALES (%): Not stated
• KEY DISEASE CHARACTERISTICS: Breast carcinoma
• OTHER KEY SAMPLE CHARACTERISTICS: All participants were overweight.

• SITE: Not stated/unknown    
• SETTING TYPE: Not specified  
• LOCATION: Not stated; however, the researchers were from Italy.

PHASE OF CARE: Active antitumor treatment

• Parallel-group
• Randomized
• Placebo-controlled

• Visual grading scale consisting of “slight (slight redness, spotty, and diffuse), moderate (moderate and uniform redness), [and] intense (intense redness)” (Togni et al., 2015, p. 1340)
• Radiation Therapy Oncology Group (RTOG) acute skin toxicity
• Photographs taken of nonirradiated and irradiated breast areas using an SLR camera without flash in ambient office exam room light, computer-assisted analysis using Adobe Photoshop CS2 with image reader, and digital evaluation of magenta color saturation in percent
• Use of a steroid cream in addition to the study cream

Significantly more visually intense erythema existed in the placebo group compared to the Boswellia group in general (p = 0.009) and when no concurrent chemotherapy was used (p = 0.018). However, no statistically significant difference existed when concurrent chemotherapy was used (p = 0.258). A highly significant decrease was observed in the use of supplemental steroid cream in the Boswellia group (25%) compared to the placebo group (63%, p < 0.0001). More participants in the Boswellia group had grade 1 RTOG scores, and more participants in the placebo cream group had grade 2 scores. However, the difference was not significance (p = 0.066). No significant differences in adverse effects existed between groups.

Further studies are needed to compare Boswellia serrata with other topical products among patients with breast cancer undergoing radiotherapy.

The process of randomization was not well described. The first two authors are employed by and fourth author is a consultant for a company that develops botanical pharmaceuticals. Patient use of both a topical steroid cream with Boswellia serrate cream may prohibit the full pharmacologic outcome of using just one topical cream.

Boswellia serrata may be useful in reducing breast radiodermatitis. However, additional larger and independent studies are needed.

To evaluate the effects of group acupuncture on specific cancer-related symptoms in persons with cancer receiving outpatient treatment

Retrospective participants completed an assessment prior to the first study and following weekly treatments; received group acupuncture at a rate of up to eight patients an hour provided in a staggered fashion by one practitioner. Meridian diagnosis established the acupoint prescription based on patient symptom complaint. Instead of standardized treatments, many factors were considered to tailor individual acupuncture treatments for the patients symptoms.

• N = 43  
• AGE RANGE = 25–84 years
• MEAN AGE = 66.1 years
• MALES: 27.2%, FEMALES: 73.8%
• KEY DISEASE CHARACTERISTICS: Breast cancer was the most common diagnosis.
• OTHER KEY SAMPLE CHARACTERISTICS: Caucasian (88.1%), non-Hispanic (76.2%)

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: West Central Florida

• PHASE OF CARE: Undescribed
• APPLICATIONS: Elder care, palliative care

• Retrospective descriptive analysis

Patients completed a pre-study and pre-treatment assessment for seven basic cancer-related symptoms (pain/numbness, dry mouth, headache, fatigue, sleep trouble, nausea, digestion) on a numeric rating scale (0–10).

Patients who completed four group acupuncture treatments reported significantly less pain/numbness and problems with digestion. There were no significant changes in any of the other symptoms (sleep, fatigue, dry mouth, headache, or nausea). Comparing baseline symptom data to week 3 revealed no significant improvement for any symptom.

This retrospective analysis pilot study of mostly patients with breast cancer with unknown treatment/medical history were evaluated over four weeks of acupuncture treatment, revealing significantly reduced reports of pain/numbness and digestive complaints after the fourth treatment. It could not be determined if this was clinically meaningful or a durable response.

• Small sample (< 100)
• Baseline sample/group differences of import
• 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)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Measurement validity/reliability questionable 
• Findings not generalizable
• Retrospective study; study subjects not ethnically diverse; symptom data presented only for four weeks; no explanation for competencies and treatment standards as performed by acupuncture practitioner(s); same or different practitioner each week unknown; predominantly patients with breast cancer; unknown phases of care; limited data description of patient population tumor types; no data for prior/concurrent treatment or side effects of therapy; potential confounding variables—inclusion/exclusion criteria; pain/numbness measured as one symptom; incomplete symptom evaluation, no standardized measurement tool for PN used; internal and external validity limited due to study design; sample characteristics and unknown sampling technique; not mentioned if assumptions were met for paired t-test