To evaluate the tolerability and activity of Kamillosan (chamomile cream) as compared to almond ointment in patients receiving radiation therapy

Patients were assigned to use one product above and the other product below their scar. The physician who evaluated the skin was blinded to which product was used on which side of the scar. The skin product was applied twice a day with the first 30 minutes before external beam radiation therapy and again at bed time. Reactions were noted after every 10 Gy and at two weeks and three months following completion.
 

• The study sample (N = 48) was comprised of female patients with breast cancer.
• Mean age of the sample was 56 years, with a range of 30–79 years.
• Patients received 2 Gy per fraction five times per week to 50 Gy (no break).

The study took place at Helsinki University Central Hospital in Helsinki, Finland.

The study used a quasi-experimental single-blinded design. Patients were used as their own controls

Adverse skin effects were graded on a four-point rating scale, with 0 being no change, 1 light erythema, 2 dark erythema, and 3 moist desquamation. Subjective evaluation was also performed, including symptoms such as pain and itching.
 

Skin changes seemed to appear later in the Kamillosan group; however, a higher proportion of the Kamillosan group developed grade 3 reactions. Overall, differences between groups were not significant. The subjective symptoms, such as itching and pain, were equally uncommon in the two groups. Most patients preferred Kamillosan because of convenience and hygienic preference.
 

Neither of the two agents prevented a skin reaction and every patient developed grade 1 erythema.

• Patients were able to decide which product went above or below the incision, leaving room for error.
• The skin grading scale is not one commonly used, and reliability or sensitivity is unknown.
• The sample size was small, with less than 50 patients.
• Since both products were used on all patients, there was no complete control and the effectiveness of either product could not be determined.
   

To compare the efficacy of sucralfate cream to a control base cream in women receiving postoperative electron beam therapy to their chest wall

Patients were randomized to apply sucralfate containing 7% micronized sucrose sulfate or equivalent base cream on either side of the scar.

N = 44

AGE RANGE = 33–84 years

MEAN AGE = 60 years

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Breast cancer of the chest wall

OTHER KEY SAMPLE CHARACTERISTICS: 6 MeV electron beam total dose 50 Gy—10 Gy weekly in five fractions. Surface area varied from 11 cm × 11cm–20 cm × 20 cm. The scar was situated horizontally in the middle of the portal image.

• SITE: Single
• LOCATION: Helsinki, Finland

• Quasi-experimental, double-blind design
  • Patients used as own controls

• Adverse effects were graded on a five-point rating scale (0 = no reaction; 1 = light erythema; 2 = dark erythema, area painful; 3 = wet desquamation; 4 = necrosis of the skin).
• Patients were interviewed for their preference of cream.

Grade 1 and 2 reactions appeared later on the areas treated with sucralfate cream. Grade 2 reactions in the entire sample were observed more often at four weeks (p = 0.01) and at five weeks (p > 0.01 but < 0.05). Recovery time of radiation-induced reactions was faster and, after finishing radiation therapy, the grade of skin reaction remained lower with the sucralfate cream than the base cream (p = 0.05).

Sucralfate may be of benefit in reducing severity of radiation dermatitis.

• No information is provided regarding patient compliance.
• What the total dose was when checked weekly is unclear.
• Where the rating scale came from is unclear.
• Small sample size

To find out the influence of rational emotive behavior therapy (REBT) on pain intensity among patients with cancer in India and Iran

The intervention included eight two-hour sessions of REBT characterized as cognitive techniques, imagery techniques, and behavioral techniques. The intervention was given to the experimental group for 45 days (10 sessions), and at the end of the intervention, pain of patients was evaluated again. Empathy, warmth, respect, relationship building, and family dynamics were covered in the first session; personal experience assessment was covered in the second session; counseling and REBT approach were covered in the third session; REBT was covered in the fourth through seventh sessions; and coping with stress was covered in the final session. Workbooks, worksheets, and practice exercises were included in the program. What the intervention actually entailed is not clear.

• N = 88
• AGE = 21–52 years
• MALES, FEMALES: Not described
• KEY DISEASE CHARACTERISTICS: Patients with cancer (no information about disease site or stage)
• OTHER KEY SAMPLE CHARACTERISTICS: None described

• SITE: Multi-site
• SETTING TYPE: Hospital
• LOCATION: India and Iran

• PHASE OF CARE: Multiple phases of care

• RCT

• McGill Pain Questionnaire

Because of errors in the tables, interpreting the findings is difficult. Data in the table are transposed from the information included in the narrative text; this makes interpretation of the information uncertain. The overall reliability of the data is in question.

The authors have asserted that an intervention resulted in reduction in pain perception, as measured by the McGill Pain Questionnaire, in an experimental group receiving REBT when compared with a control group. However, discrepancies in the article make interpretation difficult.

• Small sample (less than 100)
• Measurement validity/reliability questionable
• Other limitations/explanation: Rigor of scientific reporting is questionable.

Nurses are well aware that psychoeducational interventions can affect pain control. This study aims to support that contention. This study does not provide additional strong support in this area because of multiple study limitations.

To evaluate the effects of massage and compression in women with and without arm lymphedema secondary to breast cancer  

Women with clinically diagnosed lymphedema secondary to breast cancer and a convenience sample of women without breast cancer or lymphedema were recruited. Women who wore a compression garment removed it two hours before measurement and massage.  Measurements were taken prior to, mid way through, and at the completion of massage. Women received a therapeutic massage for one hour using the Foldi method of lymphatic drainage provided by a single trained therapist.

• The study reported on 30 female patients.
• The mean age of patients in the breast cancer group was 60 years. The mean age of patients in the nonbreast cancer group was 46 years.
• All patients with breast cancer were at least three months post-completion of any treatment. All of these patients had an interarm volume difference of at least 200 ml by perometry or bioimpedance interarm ratio greater than the standard cutoff for lymphedema.

This was a single-site study conducted in the outpatient setting in Australia.

The study used a pre/post design.

Perometry and bioimpedance techniques were used.

No statistically or clinically significant effect was found between the use of massage and limb volume with either study group.

A single session of lymphatic massage did not reduce lymphedema.

The sample size was small, with fewer than 30 participants.

 Findings suggest that a single session of lymphatic massage does not have any effect on arm volume in women with or without lymphedema.

To evaluate the effects of a psychoeducational program (COPE) on caregivers of patients with cancer

The COPE (Caregivers of Cancer Outpatients' Psycho-Education Support Group Therapy) intervention was provided to caregivers during four weeks. The program included didactic content and supportive interventions in group sessions. Study measures were obtained before and after the intervention. A subgroup was invited to participate in semistructured interviews. Caregivers were placed in one of two groups, one of which was wait-listed and used as a control in the analysis.

• N = 97   
• AGE = 21 years and older
• MALES: 35.1%, FEMALES: 64.9%
• CURRENT TREATMENT: Chemotherapy, radiation 
• KEY DISEASE CHARACTERISTICS: Patients had varied tumor types, and most had advanced disease.
• OTHER KEY SAMPLE CHARACTERISTICS: The majority had provided caregiving for 0–6 months.

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

PHASE OF CARE: Multiple phases of care

Nonrandomized, prospective, parallel group

• Caregiver Quality of Life scale
• Hospital Anxiety and Depression Scale (HADS)

No significant differences existed between study groups in postintervention caregiver quality of life overall or burden subscale scores. Those in the wait-list control group had much better quality of life scores at baseline.

The intervention studied here did not demonstrate an effect on caregiver burden or quality of life.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Substantial differences between study groups existed at baseline for quality of life and burden.

The specific psychoeducational program examined here did not demonstrate an effect on caregivers. Several limitations existed.

To determine if psychosocial interventions, led by nurses instead of mental health professionals, for patients newly diagnosed with cancer in Singapore could help ease distress, minor psychiatric morbidity, and psychosocial worry

This quasiexperimental study researched the benefits of a six-month nurse-led psychosocial intervention program for patients with newly diagnosed with cancer receiving chemotherapy. The program consisted of 20- to 30-minute sessions with a nurse and occurred monthly for two visits and bimonthly for two more visits. Participants were offered this intervention along with their treatment. Training of the oncology RNs at the National Cancer Institute in Singapore included personal training by a psychiatrist and a psychologist on psychoeducation for managing stress, sleep hygiene, anxiety, and depression and included resources, deep breathing exercises, muscle relaxation, and inspirational self-talk. Patients also received counseling, supportive therapy, and printed/audio education to encourage practice at home. The RN training also included simulated one-on-one sessions with feedback on performance. Demographic and medical data were collected. Primary outcomes were measured by questionnaires at baseline and at six months.

• N = 63
• AGE = Older than 21 years
• MEDIAN AGE = 51–60 years
• MALES: 35%, FEMALES: 65%
• CURRENT TREATMENT: Chemotherapy

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: National Cancer Institute-Singapore Medical Oncology Clinic

PHASE OF CARE: Active antitumor treatment

• Quasiexperimental study

• Distress Thermometer (DT)
• Hospital Anxiety and Depression Scale (HADS)
• EuroQol EQ-5D
• Data were analyzed using SPSS, version 22.

One hundred twenty-one participants were recruited. Seventy (58%) chose to participate, and the rest received treatment as usual (TAU). Sixty-three (90%) participants completed the four nurse-led sessions and were available at six months for reassessment. No significant demographic difference was reported between the intervention and TAU groups at baseline. No significant demographic difference existed between those followed up with and those lost to follow-up, but those lost to follow-up did have higher anxiety and depression scores at baseline. The intervention group had significantly increased distress, anxiety, and depression scores and lower EQ-5D scores at baseline. The intervention group participants had significantly reduced distress (p = 0.001), anxiety (p < 0.001), and depression (p < 0.001) scores, as well as greatly improved quality of life over time. Participants receiving TAU also showed a decline in anxiety and depression over time, with essentially stable distress scores.

A six-month intervention of psychoeducation, counseling, and behavior technique teaching improved participants’ distress, quality of life, anxiety, and depression.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%

Patients were treated with acetyl-L-carnitine (ALC) 1 g per day via IV for at least 10 consecutive days. Cisplatin neuropathy was characterized as numbness, tingling, loss of vibration sensation, and diminished proprioception.

• The sample consisted of 27 patients with paclitaxel- or cisplatin-induced chemotherapy-induced peripheral neuropathy (CIPN) aged 48–75 years.
• Potential participants were excluded if they had a European Cooperative Oncology Group performance status greater than 2 or preexisting neuropathy (not CIPN).

The study was conducted from April 2000 to December 2002.

• CIPN severity was graded using the World Health Organization toxicity grading scale.
• Clinical neurologic assessment was preformed at baseline and at the end of ALC treatment.

Of the 26 patients, 19 (73%) showed at least one grade of CIPN improvement, and all cisplatin-treated patients showed at least one grade of CIPN improvement. In addition, one patient with World Health Organization grade 2 neuropathy had complete resolution of neuropathy after 11 days of treatment. For paclitaxel-treated patients, 8 of 12 (67%) showed one grade improvement, as did 8 of 10 (80%) in the combination paclitaxel and cisplatin treatment group. The remaining patients had stable CIPN.

• Limitations included a small sample size (27 enrolled, 26 with data for analysis); the non-randomized, non-blinded design; and no control group, because of which no causality can be inferred.
• Whether the clinical neurologic examinations were conducted by the same physician using a standard approach or by different practitioners is unclear.
• No information concerning inter- or intrarater reliability was provided.
• The parameters tested and methods used to conduct the clinical neurologic testing was not provided.
• The number of variables used in the statistical tests also are unknown, making it difficult to evaluate the conclusions.

To evaluate the safety, efficacy, and pharmacokinetics of palonosetron, in combination with dexamethasone in patients receiving highly emetogenic chemotherapy (HEC)

Patients were randomized to 1 of 3 single doses of palonosetron, IV bolus (0.075, 0.25, or 0.75 mg), before administration of HEC. Subjects also received dexamethasone (12–16 mg IV on day 1, 8 mg on day 2, and 4–8 mg on day 3). All patients were hospitalized at least one day after palonosetron administration. Patients were followed up to five days. Patients used a diary to record episodes of vomiting, degree of nausea, and use of rescue medication.

• The study consisted of 231 participants.
• Mean age was 61.7 years (SD = 8.9) for the 0.075 mg group, 62.1 years (SD = 8.8) for the 0.25 mg group, and 62.0 years (SD = 9.8) for the 0.75 mg group.
• The majority of patients were male (73.2%).
• The majority of patients had lung cancer (95%), primarily non-small cell lung cancer (NSCLC).
• Patients were receiving cisplatin ≥ 50 mg/m².
• Patients were either chemotherapy naïve or had only received low or minimally emetogenic chemotherapy previously.

The study was conducted at multiple sites in Japan.

All patients were in active treatment.

This was a randomized, double blind, dose-ranging study.

• Patient diaries were used to record the date and time of emetic episodes, degree of nausea on a 0–3 scale, and use of rescue medication.
• Complete response (CR), defined as no emesis and no rescue medication, was recorded during the acute, delayed, and overall phases.
• Complete control (CC), defined as no emetic episodes, no rescue medication, and no more than mild nausea, was recorded during acute, delayed, and overall phases.
• Time to treatment failure, including time to first emetic episode or first administration of rescue medication, was recorded.
• Adverse events using Common Terminology Criteria for Adverse Events (CTCAE) were recorded.
• Pharmacokinetic analysis (palonosetron and M9 in plasma for the maximum plasma concentration, area under the curve, terminal half-life, total clearance, volume of distribution) was conducted.

• CR rates during acute phase were 77.6%, 81.8%, and 79.5% in all groups, without significant differences in different dose groups.
• CR rates increased in a dose-dependent manner during the delayed and overall phases.
• CR rates in the delayed phase were 38.3%, 49.4%, and 56.4% respectively by dose group.
• Time to treatment failure was significantly longer in the 0.75 mg group than 0.075 mg group (p = 0.0376).
• The incidence, intensity, and relation of adverse effects to palonosetron were similar among the three dose levels.
• The most frequent adverse events were constipation and headache, and most adverse events were mild to moderate.

Palonosetron at doses of 0.25 mg and 0.75 mg was shown to be effective in preventing chemotherapy-induced nausea and vomiting (CINV) in the acute phase in patients treated with HEC. CR rates in the delayed phase were less than 60% overall.

• The study did not include administration of aprepitant for HEC-related CINV.
• No discussion was provided regarding participant compliance with keeping the diary, which was the main measure for CR.
• The CR definition did not address nausea experience, and CC was not reported in detail, which addresses nausea control.

Increasing the dose of palonosetron on day one could contribute to better control of CINV during the delayed and overall phases of HEC.

To explore the effect of a previously developed Japan Outreach Palliative Care Trial of Integrated Regional Model (OPTIM) intervention on palliative care outcomes (quality of patient death and dying, family views on patient quality of care and pain control, and caregiver burden) in hospital, home, and palliative care unit settings

The OPTIM intervention focused on enhancing Japanese regional medical providers’ palliative knowledge and skills via distributions of manuals and interactive workshops and incorporating palliative care teams in educational outreach to community patients and families. The intervention also focused on holding interdisciplinary palliative care conferences and providing consumer-based information and programs on palliative care to improve regional oncologic comfort. Patients and caregivers from 23 hospitals and home-care clinics completed four questionnaires in a mailed survey sent before and following the intervention.

• N = 2,247    
• AGE: 72% aged 69 years or younger (no mean age reported)
• MALES: 29.65%, FEMALES: 70.35%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Diverse cancers (lung/gastrointestinal were most common) to support patient terminal illness 
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers were adults, able to complete questionnaires, and did not have severe emotional distress. Two different groups of caregivers responded to pre- and postintervention surveys.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Japan

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Pre-/postdesign

• Care Evaluation Scale to measure 10 domains of family-perceived quality of patient care
• Good Death Inventory to measure 18 domains of a good death in Japanese patients with cancer, included one item to measure patient pain relief 
• Caregiving Consequences Inventory to measure care burden

Significant differences (p < 0.01) were reported in quality of patient care in the home, palliative care unit, and hospital, with highest quality of care in the home. Overall, quality of care improved significantly (p = 0.04) from preintervention to postintervention in hospitals. Similar improvements at a significant level (p = 0.012) occurred in the quality of death and dying in hospitals, although this place had the lowest score at baseline compared to palliative care units and the home. No significant differences in patient pain relief occurred pre- and postintervention, nor did caregiver burden significantly increase postintervention in any of the three settings of patient death. Quality of care measures in the hospital and in some measure domains in the palliative care unit increased significantly postintervention (p < 0.05).

Caregiver quantitative feedback postintervention showed the most improvement in quality of care and of death and dying in hospitalized patients, with additional improvement in palliative care units deemed as high quality by caregivers preintervention. Caregivers consistently viewed home care as highest in quality pre- and postintervention. Family burden of care did not increase in the three settings related to the intervention. With most patient deaths in hospitals in Japan and many countries, additional efforts to improve hospital quality of care may smooth the transition of dying patients to their homes for improved family well-being.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Findings not generalizable
• Only definition of patient status was “terminally ill”
• Caregivers required to provide data in retrospective manner when recall may have been difficult
• Response rate of three groups differed to affect measurement of quality of care and quality of patient death and dying.
• Definition of family caregiver unclear in article (more than 92% of caregivers were spouses or children of the patient)
• Significant differences in age of patients and caregivers existed in preintervention and postintervention groups, and similar significance existed in place of death in both groups.
• Specifics of intervention unclear because of earlier publication of that information

Current emphasis on the delivery of high quality care to patients and their families in a variety of end-of-life settings mandates nursing attention to the feedback of patients who are terminally ill and their caregivers to meet that goal. Additional research and evidence from clinical practice offer opportunities to gain that feedback to improve care at the end of life for patients with cancer and their families.

To examine the effectiveness of two interventions, AST-120 and oral alkalization, to ameliorate diarrhea after treatment with irinotecan

• Patients with varying cancers who were receiving irinotecan were given AST-120, oral alkalization, or nothing (control).
• AST-120 (Kremezin™) is an oral adsorbent made of activated carbon. Patients received 2 g at the start of irinotecan infusion, immediately after irinotecan infusion, and three hours after irinotecan infusion.
• Oral alkalization, consisting of 2 g NaHCO₃ (sodium bicarbonate), 2 g magnesium oxide, and 300 mg ursodexycholic acid, was given before irinotecan and then daily for three days after irinotecan administration.

The study reported on 13 Japanese patients with cancer receiving 60–100 mg/m² irinotecan every 1–2 weeks, alone or as part of a combination regimen. The control group consisted of 7 patients, the AST-120 group consisted of 4 patients, and the oral alkalization group consisted of 4 patients. One patient in each of the two intervention groups served as his or her own control, having received prior irinotecan with no prophylaxis.

This was a nonrandomized trial.

Patients recorded the number of bowel movements but not the volume.

• Oral alkalization appeared to be effective in ameliorating diarrhea, although the efficiency did not reach a significant difference (level of significance not indicated).
• AST-120 significantly decreased the maximum number of daily bowel movements during irinotecan treatments as compared with no prophylaxis (p < 0.05).

• This was a small study with only 13 patients.
• One patient in the AST-120 group and one patient in the oral alkalization group acted as his or her own control. Only three other patients were in each interventional treatment group.

Although further study is necessary regarding the effect of oral AST-120 on plasma concentrations of irinotecan-related compounds, it is speculated that the absorption of irinotecan or SN-38 from the intestinal lumen is small, if any, and the remaining irinotecan-related compounds in the intestinal lumen cause diffuse mucosal damage in irinotecan treatments.