To compare pain outcomes with two different radiotherapy dosing schedules for pain associated with bone metastases

Referred patients were allocated to two different dosage groups based on the discretion of the radiation oncologist. Pain was assessed at the end of treatment and on days 8, 15, and 30 in follow-up.

• N = 187
• MALES: 64%, FEMALES: 36%
• KEY DISEASE CHARACTERISTICS: Breast, lung, prostate, renal, and thyroid cancers; 71% had metastases only on vertebrae

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

Prospective study

• Visual Analog Scale (VAS)

In total, 62% of patients received a single fraction of 8 Gy and the rest had 10 fractions of 3 Gy. There were no significant differences between these groups in overall pain reduction.

Single and multiple fraction radiation therapy schedules provided similar results for the control of pain from bone metastases.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Subject withdrawals ≥ 10%
• Other limitations/explanation: No information on analgesic or bone modifying agent use was provided. There was no intent to treat analysis for patients lost to follow-up. No sample demographics were provided.

Single fraction radiotherapy for pain control appeared to be as effective as multiple fraction dosing. Single fraction dosing may provide a more practical and convenient alternative for pain control. There could be differences in adverse effects, which were not discussed in this report.

To evaluate the effects of the hospital-based palliative care team on care for patients with cancer

The hospital-based palliative care team visited intervention patients “regularly” during the one-week study period. Team members including physicians, nurses, chaplains, and social workers provided advice about medications and taught patients and families skills to relieve physical symptoms, provided emotional support, and assisted with truth-telling and preparation for death. Data were collected at baseline and one week later.

• N = 60
• MEAN AGE = 57.5 years (SD = 14.62)
• MALES: 57%, FEMALES: 43%
• KEY DISEASE CHARACTERISTICS: Patients with advanced cancer with palliative care needs
• OTHER KEY SAMPLE CHARACTERISTICS: Patients hospitalized in a medical center in Taiwan; unlikely to die or be discharged in 24 hours

• SITE: Single site
• SETTING TYPE: Inpatient   
• LOCATION: Taipei, Taiwan

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

Quasi-experimental study with a pretest-posttest design

• Symptom Distress Scale (SDS)
• Hospital Anxiety and Depression Scale (HADS)
• Spiritual Well-Being Scale
• Social Support Scale

No significant difference was seen in anxiety and depression between the control and intervention groups after one week of palliative care. Improvement was seen in edema, fatigue, dry mouth, and abdominal distention.

Nurse interventions improved symptom management for the intervention group; however, in the short timeframe of this study emotional disturbances were not affected. Cultural implications are important here; death is a taboo topic in Chinese culture, and patients' understanding of their terminal disease is low and rarely discussed.

• Small sample (< 100)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Patients were given the choice of usual care plus visits from the palliative care team versus usual care alone. The timeframe was only one week, and the number of visits and disciplines of the palliative care team were not clearly described. Nurse interventions for some physical symptoms are described very generally; no interventions for depression or anxiety are described.

Palliative care consultation may benefit many symptoms of patients with cancer, but without clear interventions for depression and in this short timespan, little effect is apparent.

To determine whether concurrent pyridoxine therapy can prevent the development of hand-foot syndrome (HFS) in patients being treated with capecitabine. 

Chemotherapy-naïve patients with gastrointestinal (GI) tract cancers who were scheduled for capecitabine-containing chemotherapy were randomly assigned to concurrent oral pyridoxine (200 mg per day) or placebo. Patients were stratified by chemotherapy regimen and monitored until development of HFS with a National Cancer Institute (NCI) common toxicity criteria of grade 2 or worse, or capecitabine-containing chemotherapy ended. Patients in the placebo group who developed grade 2 or worse HFS were randomly assigned again to received pyridoxine or placebo in the next chemotherapy cycle to determine whether pyridoxine could improve HFS.

• The study reported on a sample of 360 patients with GI tract cancers.
• Median patient age was 56 years.
• The sample was 67% male and 33% female in the pyridoxine group, and 58% male and 42% female in the placebo group.
• Most patients had colon cancer and were scheduled for adjuvant capecitabine monotherapy. The next largest group comprised patients with stomach cancer who were receiving palliative capecitabine and cisplatin, or docetaxel, capecitabine, and cisplatin.
• Patients in both arms received a median of six cycles of chemotherapy.

The site and setting types were not specified.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blinded, placebo-controlled trial.

•  Kaplan-Meier curves
•  NCI Common Terminology Criteria for Adverse Events (CTCAE), version 2.0
   

• Fifty-seven of 180 pyridoxine-treated patients (32%) and 55 of 180 placebo-treated patients (31%) developed grade 2 or worse HFS.
• Randomization of the 44 patients in the placebo group with grade 2 or worse HFS to placebo or pyridoxine for the next cycle resulted in no significant difference in the proportion showing improvement of HFS.

Pyridoxine is not effective in the prevention of capecitabine-associated HFS.

This trial did not include pathophysiologic analysis, which could have provided additional information on the pathogenesis of capecitabine-induced HFS.

Pyridoxine prophylaxis was shown to have no effect on reducing the development or severity of HFS.

STUDY PURPOSE: To conduct a systematic review and meta-analysis on nonpharmacologic interventions (psychosocial and exercise) for cancer-related fatigue (CRF)

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 57 RCTs included in the meta-analysis, 116 published articles for systematic review
• TOTAL PATIENTS INCLUDED IN REVIEW = 4,621 in meta-analysis
• SAMPLE RANGE ACROSS STUDIES: Not reported
• KEY SAMPLE CHARACTERISTICS: Of the patients, 33%–45% had breast cancer and were in a mix of stages and treatment statuses.

PHASE OF CARE: Multiple phases of care

Both psychosocial interventions and exercise showed benefit in CRF. Psychosocial interventions had a small to moderate effect on fatigue; exercise had a moderate effect. No significant differences existed in the effect of exercise on CRF between psychosocial interventions and exercise. Exercise showed a stronger effect during treatment than post-treatment, whereas psychosocial interventions showed a stronger effect post-treatment.

Both psychosocial interventions and exercise are beneficial in ameliorating CRF. A multimodal approach across all phases of treatment is best.

• Limited search
• High heterogeneity
• Somewhat dated review; latest published article included was 2006

Provides additional support for psychosocial interventions and exercise for CRF. Because of the heterogeneity of interventions, supporting one type of psychosocial intervention or exercise regime over another is difficult. Nurses can incorporate interventions acceptable to patients.

To conduct a controlled pilot trial evaluating the efficacy of a brief early cognitive behavior therapy intervention (CBT) to reduce symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety and to prevent chronic psychological problems within the first year following diagnosis of head and neck cancer

Patients with elevated levels of PTSD, anxiety, or depression were randomized to seven individual sessions of either CBT or nondirective supportive counseling (SC). The interventions were concurrent with radiation therapy. The primary outcomes (PTSD, anxiety, and depression) and secondary outcomes (cancer-related appraisals, quality of life)  were assessed at baseline, one month, six months, and one year postintervention. Researchers assessed participants by using diagnostic clinical interviews and self-report questionnaires. Participants completed the screening assessment conducted by trained psychologists and were then randomized to either a CBT or SC group. Assessors blinded to treatment group conducted follow-up assessments. Researchers conducted a random evaluation of 25% of participants to ensure clinician adherence to protocol.

• The study reported on a sample of 35 participants.
• Mean patient age was 54.8 years, with a range of 18–70 years.
• The sample was 80% male and 20% female.
• Patients had primary head and neck cancer, first onset.
• Patients were recommended to receive primary radiation therapy (XRT) or adjuvant XRT, had an expected prognosis of more than 12 months, and were English speaking.
• There were no differences in sociodemographic or medical variables.

• Single site
• Setting type unspecified
• Royal Prince Alfred Hospital, Sydney, Australia

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A pilot randomized controlled trial design was used.

Assessors administered the following at each assessment:

• Clinician-administered PTSD scale
• Structured Clinical Interview for DSM-IV Axis IV disorders (SCID-IV)
• Posttraumatic Stress Disorder Checklist (PCL), stress-specific version
• Beck Depression Inventory (BDI)
• Posttraumatic Cognitions Inventory (PTCI)
• Functional Assessment of Cancer Therapy–General
• Treatment Credibility Scale (TCS), adapted to measure patient’s beliefs about treatment efficacy contingent on the intervention to which patient was randomized (CBT or SC)

In spite of randomization, the CBT group, compared to the SC group, had significantly elevated scores on the PTCI self-blame subscale. This finding was included as a covariate. Participants in both treatment interventions reported a decline in anxiety and symptoms of depression over time. The study found no significant interaction effects between the two groups in regard to world outlook and negative appraisals. However, a main effect of time was evident for the PTCI negative scale, with both groups reporting a reduction in negative self-referent appraisal scores at one and six months. Significant main effects of time were also evident for improvements in quality of life and on all four subscales in both treatment groups. This was most evident at 6 and 12 months post-therapy. There were no significant differences between groups, and effect size (Cohen’s d) was not significantly different for anxiety or depression outcomes.

The findings of this study indicate that early intervention with psychotherapy is useful in reducing anxiety and symptoms of depression and PTSD and for preventing chronic psychopathology in symptomatic patients with head and neck cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no control group, no appropriate attentional control condition, and limiting sample characteristics.
• Findings are not generalizable.
• The intervention is expensive or impractical and is accompanied by need for training.
• The study involved English-speaking patients only, and mainly Caucasian males.
• Cancer type was limited to head and neck cancer.

Early identification and intervention for patients who are newly diagnosed with head and neck cancer may be beneficial in reducing symptoms resulting from PTSD, anxiety, and symptoms of depression related to diagnosis. Early identification and intervention may prevent chronic psychological issues in the patient population studied. This study showed that both CBT and SC had similar effects. Findings are limited by lack of a control group and the fact that, with or without treatment, all patients' anxiety levels tend to decline over time.

To evaluate the efficacy and safety of topically applied recombinant human epidermal growth factor (rhEGF) for the prevention of radiation-induced dermatitis in patients with cancer

EasyDew CR cream (0.005% rhEGF, ceramide, hyaluronic acid, Inca omega oil, portulaca oleracea extract, mango butter, and meadowfoam oil) was applied to the radiation portal skin twice per day from day 1 to the last day of radiation treatment (RT). Patients were advised to wash the cream off prior to RT. No other prophylactic creams or lotions were allowed, and additional applications were ceased if an adverse reaction occurred because of the rhEGF-based cream. Compliance in applying the cream was evaluated weekly by the treating radiation oncologist.

• N = 1,138
• MEAN AGE = 51 years (range = 18–90 years)
• MALES: 17.6%, FEMALES: 82.4%
• KEY DISEASE CHARACTERISTICS: Histologically-confirmed breast (73%), head & neck (13%), others combined (14%; cervical, soft tissue, esophagus, lung, rectum, and thymus)
• OTHER KEY SAMPLE CHARACTERISTICS: All participants received > 50 Gy of external radiotherapy, but the mode varied (photons [51.8%], electrons [4.6%], and photons with electrons [43.6%]).

• SITE: Multi-site
• SETTING TYPE: Outpatient
• LOCATION: Twenty-one cancer centers in Korea

• PHASE OF CARE: Active antitumor treatment

Multi-site, prospective, observational study of the efficacy and safety of rhEGF cream to prevent radiodermatitis (in patients receiving more than 50 Gy of external radiotherapy)

• Modified Radiation Therapy Oncology Group (RTOG) Acute Skin Toxicity Scale
  • The authors commented, “This scale of radiation dermatitis was modified with a representative sign to reduce interobserver variations.” The presence of edema, dry skin, and pruritus also were measured. The status of pruritus was scored using the following criteria: grade 0, no pruritus; grade 1, mild or localized, relieved spontaneously; grade 2, mild or localized, relieved by local measures; grade 3, intense or widespread, relieved by systemic measures; and grade 4, intense or widespread and poorly controlled despite treatment.

This study showed that the intervention used was not associated with any severe adverse reactions, but it provides no real evidence regarding the efficacy of the rhEGF cream.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (sample characteristics)
• Other limitations/explanation: There were 21 centers and no mention of the number of raters used, how the raters were trained, or measurement of inter-rater reliability. The standard RTOG scale was modified. Skin toxicities had Common Terminology Criteria for Adverse Events (CTCAE) variations. RT doses were not surveyed using a method. The objective radiation dermatitis assessment tool needed improvement.

Additional studies of this cream are needed before considering the use of this cream in practice. The authors addressed pruritus and radiation toxicity as being potential adverse events; however, they do not stress the importance. Pruritus has been demonstrated to negatively impact quality of life.

To determine symptom changes after outpatient palliative care

Patients who were seen in outpatient palliative care and had completed a symptom assessment scale were included in retrospective review of medical records. Only patients who completed the assessment and had at least one follow-up visit were included. The outpatient palliative care service was provided by an interdisciplinary team. Baseline symptom severity was compared to findings on an initial follow-up—usually in 15 days—and compared to a group of patients not eligible for study inclusion.

• N = 1,612 
• MEAN AGE = 59.2 years (SD = 13.2 years)
• MALES: 52%, FEMALES: 48%
• KEY DISEASE CHARACTERISTICS: Multiple disease types; lung, gastrointestinal, and genitourinary cancers were most frequent.
• OTHER KEY SAMPLE CHARACTERISTICS: 73% were Caucasian.

• SITE: Single site 
• SETTING TYPE: Outpatient 
• LOCATION: MD Anderson in Texas

• APPLICATIONS: Palliative care

• Retrospective, descriptive

• Edmonton Symptom Assessment Scale

Of the patients, 52%–74% had improvement in intensity of symptoms of pain, fatigue, depression, anxiety, anorexia, shortness of breath, and sleep disruption. Overall, among patients who had no or mild symptoms at baseline, symptom intensity was worse at follow-up, and among those with moderate or severe symptoms, symptom intensity declined at follow-up. Of patients with moderate or severe symptoms, 48%–80% continued to have clinically significant symptom intensity at follow-up. Median scores for pain, fatigue, depression, anxiety, anorexia, dyspnea, and sleep disturbance improved by at least one point by the first follow-up (p < .001).

Outpatient palliative care services in this setting were associated with reduced symptom intensity among patients who had moderate to severe symptoms. Findings suggest that the timing of initial follow-up might not be sufficient to significantly reduce symptom burden quickly.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Selective outcomes reporting
• Other limitations/explanation: Retrospective design; no information provided regarding disease stage or phase of cancer care involved; only a single follow-up time point

Findings suggest that provision of outpatient palliative care services can be beneficial in reducing symptom burden among patients with cancer. Because 48%–80% still had relatively high intensity of symptoms at follow-up after 15 days—and those with no or mild symptoms had exacerbation of symptoms at follow-up—a shorter initial follow-up period might achieve more rapid improvement and help to prevent exacerbation of symptoms. Findings also suggest that getting more severe symptoms under control may take longer, pointing to the need for nurses to consider involvement of palliative care specialists early in the course of cancer treatment.

To assess the efficacy and safety of oral formulations of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric patients aged six months to 17 years scheduled to be treated with moderately or highly emetogenic chemotherapy

Patients were randomly assigned (but stratified by age) to the aprepitant or control regimen and were divided into two age groups: less than 12 and 12–17 years. All patients received ondansetron. Patients over 12 received a 125 mg aprepitant capsule on day 1 and 80 mg on days 2 and 3 in the aprepitant arm. The control arm received a placebo daily plus ondansetron on day 1. Patients under 12 in the aprepitant arm received powder for suspension at 3 mg/kg on day 1 with ondansetron and 2 mg/kg of aprepitant on days 2 and 3. The control regimen again received a placebo daily plus Zofran on day 1. Investigators were able to add dexamethasone at their discretion with dose reductions of 50% based on adult pharmacokinetic data.

• N = 302  
• MEDIAN AGE = 7.5 years (range = six months to 17.8 years)
• MALES: 84 (55%) aprepitant group, 79 (53%) control group, FEMALES: 68 (45%) aprepitant group, 71 (47%) control group
• KEY DISEASE CHARACTERISTICS: Patients with a documented malignancy (original or relapse) who were scheduled to receive chemotherapy with at least a moderate risk of emesis and who were expected to receive ondansetron as part of their chemotherapy-induced nausea and vomiting (CINV) regimen
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria: Vomiting 24 hours before day 1 of treatment, symptomatic primary or metastatic central nervous system malignancy causing nausea or vomiting, abdominal or pelvic external radiation therapy one week prior to treatment, use of antiemetics 48 hours before treatment, or any CYP3A4 substrates or inhibitors within seven days or inducers within 30 days of treatment

• SITE: Multi-site    
• SETTING TYPE: Not specified    
• LOCATION: Twenty-four countries

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

Phase 3, multicenter, randomized, double-blinded, active-comparator, controlled, parallel-group trial

• Patient diaries recorded episodes of vomiting, retching, or use of rescue medication.
• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE v.4)
• Laboratory tests (complete blook count, chemistries, and urinalysis) and electrocardiogram

Fifty-one percent of patients in the aprepitant group achieved a complete response in the delayed phase versus 26% in the control group (p < 0.0001). The number of patients with no vomiting or rescue medication use was greater in the aprepitant group than the control group in all phases (47% versus 21% for no vomiting and 66% versus 49% for no rescue medication). The median time till the first vomiting episode was greater in the aprepitant group (96.3 hours versus 27.5 hours), and the time to first rescue medication use also was significantly longer in the aprepitant group compared to the control group. The number of patients who achieved a complete response was similar for patients aged less than 12 years receiving a powder suspension and those who received capsules. Adverse events were reported equally between groups. Serious adverse events were reported in 30% of the aprepitant group and 27% of the control group (most commonly febrile neutropenia).

A three-day age and weight adjusted oral aprepitant regimen given in combination with ondansetron with or without dexamethasone safely provided a significant benefit in preventing CINV in moderately to highly emetogenic chemotherapy in a pediatric population.

• Investigators added dexamethasone at their own discretion in a population that may have had a potential bias toward poorer outcomes and patients who may have had a greater history of emesis or more emetogenic chemotherapy.
• The study was funded by Merck and Co, Inc., who determined the study design, conduct, data collection, and analysis.

The addition of aprepitant to ondansetron with or without dexamethasone was safe and may be effective in the prevention of CINV in pediatric patients receiving moderately to highly emetogenic chemotherapy.

To evaluate the efficacy of fluconazole prophylaxis during chemotherapy-induced neutropenia.

Databases searched were MEDLINE, CancerLit, and the Pfizer company database through April 1999 (no start date was provided). The search was not restricted to the English language or published trials.

Sixteen trials were evaluated.

Studies were included if they

• Were prospective and randomized.
• Compared oral fluconazole with placebo, no treatment, or oral polyenes (nystatin, oral amphotericin B).
• Used a neutropenia definition of less than 1000/mcl and did not use intravenous (IV) antifungals.
• Reported the incidence of fungal infection.

Data from the meta-analyses reported the combined population, bone marrow transplant (BMT) recipients only, and non-BMT recipients only.

A total of 3,734 patients were evaluated. Some studies exclusively examined BMT recipients, others studied non-BMT recipients, and others evaluated a combined population.

Prophylactic fluconazole was not effective in

• Reducing fungal-related death in non-BMT recipients (although it was effective in BMT recipients).
• Reducing proven systemic fungal infections in non-BMT recipients (although it was effective in BMT recipients).

Prophylactic fluconazole was effective in

• Reducing superficial fungal infections in non-BMT and BMT recipients.
• Reducing the use of amphotericin B for persistent neutropenic fever in the BMT population (this could not be concluded for the non-BMT group).

Prophylactic fluconazole did not increase rates of proven systemic infection with resistant strains in the non-BMT or BMT populations.

Colonization of fluconazole-resistant fungi increased with prophylactic treatment in BMT recipients; however, information about non-BMT recipients is inconclusive because of lack of power and paucity of data.

To investigate the effects of low-dose aspirin on some adverse effects of gefitinib

Patients were recruited when admitted to the hospital for assessment of lung cancer. For the first two years, patients did not receive aspirin. In 2003, patients were started on aspirin 100 mg/day along with gefitinib treatment. Nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids were continued in all patients.

• The study reported on 40 patients.  
• Median age was 67 years, with a range of 42–82 years.
• The sample was 60% male and 40% female.
• All patients had lung cancer, with approximately 60% having stage IV disease.
• Some patients who did not receive aspirin also were getting concurrent chemotherapy in addition to the EGFRI.

• Single site
• Inpatient setting
• Japan

Patients were undergoing active antitumor treatment.

The study was a retrospective analysis of treated versus untreated cases.

No instruments or methods were described for toxicity rating.

Overall frequency of EGFRI-related adverse events was 77.8% in those not treated with aspirin and 58.3% in those who received aspirin. Skin rash incidence was 33.3% in those on aspirin and 74.1% of those not on aspirin. There was no apparent difference in gefinitib response between groups.

Findings suggest that aspirin may help to reduce the incidence of some gefinitib toxicities, however, no clear conclusions can be made due to study limitations.

• The study had a small sample, with less than 100 participants.
• The study had baseline sample/group differences of import.
• The study had risk of bias due to lack of control group, blinding, and random assignment.
• Measurement/methods were not described.
• Definition of toxicities and skin rash were not stated, and no statistical analysis was done to determine any difference in incidence reported.
• Historical group not on aspirin was stated to also be receiving other chemotherapy, which could have affected toxicity development.
• Concomitant use of steroids and NSAIDs was stated but not described.

This study aimed to report the effects of low-dose aspirin for prevention of toxicities with gefinitib. The study does not provide strong support for this intervention; however, results suggest that further research in the use of low-dose aspirin could be beneficial.