To determine if use of mometasone furoate (MMF), a corticosteroid cream could reduce intensity of erythema in acute radiation dermatitis

Patients were randomized to receive tubes of either MMF cream 0.1%  or an emollient cream as a placebo control. Patients were instructed to apply the cream on the irradiated area twice a week up to 24 Gy and then once daily for the rest of treatment and three weeks after completion of radiation therapy. All patients in both study groups also applied the emollient cream over the radiated area once daily throughout the entire study period.

• The study sample (N = 50) was comprised of female patients with breast cancer who had undergone breast-conserving surgery.
• Mean age was 58 years for the MMF group and 60 years for the control group.
• All had a World Health Organization performance status of 0.
• A 5 MV photon beam was delivered in 2 Gy fractions for a total dose of 54 Gy.

The study took place in Uppsala, Sweden.

The study used a randomized double-blind controlled design.

• Skin reaction was measured with a seven-point grading scale, from 0 (no reaction) to 6 (moist desquamation) evaluated in five defined skin regions at each visit. Maximum scores were used in analysis.
• Patients’ subjective experiences of itching, burning, and pain were measured using a visual analogue scale.
• The Mann Whitney U test was used for all statistical comparisons.
• A reflectance spectrophotometer was used to rate erythema. The device emits various light colors corresponding to absorption peaks of hemoglobin and melanin.
• The intensity of emitted light as measured by a photo detector was used to provide a patient erythema index and a patient melanin index. These indexes were calculated as the mean of three assessments in each of five skin regions identified for each patient.

• The two-photon excitation was lower in the MMF group (p = 0.033)
• The maximal skin reaction grade was lower in the MMF treated group (p = 0.011).
• Six patients in the control group required further topical treatment because of severe subjective symptoms. Three patients in the MMF group needed further treatment of severe moist desquamation in the axilla.
• Patients in the MMF group reported less itching and burning, but the differences were not statistically significant.

MMF patients showed less pronounced erythema, less itching and less burning than emollient group. MMF may provide a benefit.

• The study had a small sample size, with less than 100 participants.
• Reliability of the seven-point scale was not stated, and it was not clear who was making observations.
• There was no log for application of the creams, so compliance with the planned regimen was not clear. The study did show that two patients did forget to apply the MMF during the treatment period.
• The study did not report if other skin regimens, such as washing, were allowed.
• Both groups applied the control emollient cream, so it is unclear what effect this had on skin reactions

To determine the effectiveness of using fentanyl buccal tablets (FBT) to reduce pain related to placing indwelling vascular access ports in opioid-naïve patients with cancer

Patients were assessed on anxiety and pain preoperatively. Ten minutes prior to the procedure, 100 mcg FBT was administered. Patients were assessed postoperatively on pain during the procedure. Side effects and symptoms were monitored during, after, and four hours after the procedure. Those with anesthesia-related nausea received one metoclopramide tablet one hour prior to the procedure, and those with extreme pain during the procedure received rescue therapy of 30 mg ketorolac or 20 drops of tramadol if allergic to NSAIDS/ASA.

• N = 65   
• AGE = 18 years and older
• MALES: 29.2%, FEMALES: 70.8%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Participants were 18 years or older, had indication for port as an inpatient, were cognitively intact, and had written informed consent. Exclusion factors: xerostomia; treatment for chronic cancer pain with opioids; history of nausea and vomiting to opioids or intolerance to fentanyl or FBT; chronic respiratory insufficiency; hepatic or renal function impairment.

• SITE: Not stated/unknown   
• SETTING TYPE: Inpatient    
• LOCATION: Inpatient

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Phase II pre-/poststudy design

• Four-point Likert-type scale for pain
• State-Trait Anxiety Inventory Form Y (STAI-Y)

• Significantly lower perception of pain in those treated with FBT than those not treated with FBT (p = 0.0018)
• Drowsiness reduced from after procedure to four hours post-procedure (p < 0.01)
• Vertigo reduced from after procedure to four hours post-procedure (p < 0.02)
• No significant findings with respect to nausea, vomiting, vital signs, and other side effects

Use of FBT pre-procedure to reduce pain perception is a plausible intervention for pain control in those receiving a port but is not without side effects. Further consideration to prevent or ameliorate side effects and further studies with a larger population should be considered.

• Small sample (< 100)
• 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
• Findings not generalizable
• These patients were compared to 2010–2011 patients, and so retrospective report and not knowing potential conditions impacting reporting is a weak area of this study

Nursing would need to be prepared for management of side effects and potential fall risk post-procedure. Side effects could require restructuring the postoperative environment to meet the needs of the patients or require follow-up beyond four hours.

To evaluate the relationship between antiemetic effect and well being over four different antiemetic treatment strategies

• The study consisted of a total of 162 chemotherapy-naive patients with ovarian cancer.
• All patients received similar combination chemotherapy, including cisplatin (50 mg/m²).

This study was conducted in the greater Stockholm, Sweden, area, with two gynecologic oncology wards.

Patients were randomly admitted to one of the two hospital wards for the study. Study II was a randomized, double-blind trial on the same hospital wards.

• Patients completed self-assessment questionnaires the day after and two weeks after chemotherapy.
• Presence, frequency, and intensity (on a 0–100 visual analog scale [VAS]) of nausea and vomiting was recorded. 
• Duration of acute nausea, including time of onset and number of hours until relieved, were recorded.
• Delayed nausea, including the number of days with any symptoms, was recorded for two weeks after chemotherapy.
• Questionnaires were administered regarding well-being before, during, and after chemotherapy.
• A 0–100 VAS was used to measure aspects of quality of life and well-being.

• Relief from delayed symptoms was highest in the group that received high-dose metoclopramide (2.5 mg/kg x 2), dexamethasone (20 mg x 1), lorazepam (1 mg x 2), and biperiden (1-2 mg x 3) followed by low-dose metoclopramide (20 mg x 3) orally for three days after chemotherapy.
• Nausea intensity was lowest in the group that received ondansetron (8 mg x 3) and dexamethasone (20 mg x 1) IV during the chemotherapy day and ondansetron orally (8 mg x 3) for five days after chemotherapy.
• Duration of acute nausea was shortest in the high-dose metoclopramide group. The high-dose metoclopramide and the ondansetron and dexamethasone groups reported better well-being.
• Duration of acute nausea was the only variable that was significantly related to well-being in both samples.
• Relaxation training was offered to 20 patients in the ondansetron and placebo group and 18 patients in the ondansetron and dexamethasone group; no differences were found in the studied variables.

• Some patients received a benzodiazepine, but no comparison regarding effect can be made.
• All patients had ovarian cancer, were in the same department, and were treated with similar chemotherapy.

To provide information about organizational experience with use of pegfilgrastim following dose intensive chemotherapy for solid tumors in pediatric patients with cancer.

Medical records of patients receiving myelosuppressive therapy supported with pegfilgrastim were reviewed (cases from 2007–2008). By protocol, pegfilgrastim was given in the outpatient clinic by subcutaneous injection at 0.1 mg/kg to a maximum does of 6 mg 24–48 hours after completion of chemotherapy. Complete blood counts (CBCs) were routinely monitored  every 7–10 days during therapy cycles, then every 2–5 days until neutrophil recovery. Analysis was limited to the first four courses of chemotherapy.

• 47 patients completed 176 courses of chemotherapy.
• Median age was 13 years, with a range of 2 months to 23 years.
• Females made up 53% of the sample; males made up 47%
• Key disease characteristics included Hodgkins disease, rhabdo myosarcoma, neuroblastoma, osteosarcoma, and Ewing sarcoma.
   

• Single site
• Outpatient
• Seattle, WA

• The phase of care was active antitumor treatment.
• The application was for pediatrics.

Retrospective descriptive

• Severe neutropenia was classified as an absolute neutrophil count (ANC) of less than 200 mm³
• Neutrophil recovery was an ANC greater than 200 mm³
• Febrile neutropenia was defined as severe neutropenia with temperature of 38.3ºC or higher with hospitalization and parenteral antibiotic therapy.
   

There were no significant adverse effects observed with pegfilgrastim. Leukocytosis was observed in 73% of patients, with no adverse sequelae. Severe neutropenia occurred in 57% of chemotherapy courses, and febrile neutropenia was seen in 28% of courses. Course delay occurred in 9% of courses, with a mean duration of two days of delay.

 This report provides evidence regarding the safety and efficacy of pegfilgrastim among a pediatric cancer population.

• 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
• Key sample group differences that could influence results
• Retrospective study design with associated risk of bias in results. 
• No information is provided regarding any other prophylactic medications for prevention of infection in this population.

Findings suggest that pegfilgrastim is effective and can be safety given to pediatric patients.

To evaluate a method of mechanical lymphatic drainage using the RAGodoy apparatus

Lymphedema was confirmed with lymphoscintigraph and volumetry and defined as a difference in arm volumes of more than 200 ml. Patients had a one-hour session with the RAGodoy mechanical apparatus, which provides 15–25 elbow bending and stretching exercises per minute. Pre- and post-treatment volumetry was taken.

• The study sample was comprised of female patients with breast cancer who were experiencing arm lymphedema.
• The sample age range was 42–86 years.

The study took place at a single outpatient site in Brazil.

The study used a prospective trial design.

The reduction in the volume was an average of 59.2 ml (p < 0.001). In two cases, there was an increase in volume with the intervention. In the remaining 23, there was a decrease in volume. It appeared that for those where there was an increase, the patients did not fully allow the device to passively work.

Passive mechanical exercise for lymphatic drainage may be helpful in the management of lymphedema

• The sample size was small, with less than 30 participants.
• The report was brief with limited data and sample characteristics provided.
• The apparatus appeared to have been developed by the authors, so potential for bias must be considered.
• The study reported on single use only; repeated or longer-term use of the approach is unknown.

Use of a device for provision of passive limb exercise in the management of lymphedema requires further study.

STUDY PURPOSE: To explore the effectiveness of pharmalogic and nonpharmalogic agents in treating hot flashes in breast cancer survivors

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 4 nonpharmacologic and 22 pharmacologic
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,930 patients (779 nonpharmacologic; 1,151 pharmacologic) 
• SAMPLE RANGE ACROSS STUDIES: 47–347
• KEY SAMPLE CHARACTERISTICS: Breast cancer survivors, clinical characteristics not specified and length of follow-up not described

PHASE OF CARE: Transition phase after active treatment
 
APPLICATIONS: Elder care

CAM therapies and vitamin E appear to have some effect, but data are limited. Gabapentin and some of the newer antidepressants were the most effective, with some side effects. These studies had small to moderate sample sizes, which makes overall effectiveness difficult to establish.

• Limited search
• No quality evaluation
• High heterogeneity
• Older article (2007)
• Hormone replacement therapy was not accepted by women

Nurses need to know the negative effects of hormonal agents on safety. Nonpharmacologic agents, such as soy phytoestrogens, black cohosh, and vitamin E, appear to be ineffective and limited because of the methodological limitations of studies. Gabapentin and some of the newer antidepressants were the most effective but still have side effects.

Evaluate the efficacy of venlafaxine versus gabapentin for hot flashes in breast cancer survivors

Patients were randomly assigned to receive venlafaxine for 4 weeks, then after a 2-4 week washout receive gabapentin for 4 weeks, or to have the medications in the reverse order.    Patients were given venlafaxine 37.5 mg daily for 7 days and then 75 mg daily for 21 days.  Gabapentin was given at 300 mg at bedtime for 3 days, then 2 times daily for 3 days, then 3 times daily for 22 days.  Patients completed a hot flash diary daily.  At baseline, and at the end of each study period, they completed a symptom rating and study questionnaires.

• N = 58
• AGE   Median 55, range 39.6 - 78.7
• MALES (%)          FEMALES (%)100%
• KEY DISEASE CHARACTERISTICS
  • All had previous breast cancer and were from 0-20 years since diagnosis. 
  • All had history of bothersome hot flashes. 
  • 79% had hormonal therapy. 
  • 18% had previous treatment for hot flashes.

• SITE  Multi-site 
• SETTING TYPE  Outpatient 
• LOCATION Canada

PHASE OF CARE Late effects and survivorship

Crossover RCT

• SF -36
• Hot flash severity on VAS
• Hot flash diary
• Quality of Life Questionnaire

Only 38 patients completed all 4 weeks of both drugs, and 12% of those initially entered dropped out.  Of patients who provided data regarding drug preference, the majority preferred venlafaxine (p = .01).   There were no significant differences between treatments on hot flash outcomes, and hot flash scores were reduced from baseline in both groups (p<.001).  Venlaxafine was associated with loss of appetite (p<.01), nausea ( p = .02), constipation (p =.05), and fewer negative mood changes (p = .003).  Gabapentin was associated with more dizziness ( p = .005) and increased appetite (p<.001).  Hot flash scores in all subjects increased during the 2-4 weeks off therapy.  There were no serious adverse effects of the medications.

• Both gabapentin and venlaxafine reduced hot flash severity in these patients. 
• Each medication was associated with (differing) side effects. 
• More patients preferred venlaxafine.

• Small sample (< 100)
• Risk of bias (no blinding)
• Subject withdrawals ≥ 10%
• Other limitations/*explanation  It is not clear if patients or observers were blinded to treatment assignments. Subjects not stratified based on age.

The findings suggest that either venlafaxine or gabapentin can be effective in reducing hot flash symptoms in breast cancer survivors.  More patients preferred venlafaxine.  Both drugs have side effects.

The objective of this study was to discuss the evidence for our present understanding of the symptom of dyspnea and unanswered questions regarding the genesis and management of cancer-related breathlessness.

Databases searched were MEDLINE, CINAHL, and EMBASE (1966-2006). 

Search keywords were breathlessness, cancer, lung cancer, cancer, dyspnea/dyspnoea, intervention, management, and nonpharmacological.

Studies were included in the review if they were double-blind, randomized, randomized- controlled, or placebo-controlled trials, case reports, or uncontrolled trials that

• Defined the experience of breathlessness
• Assessed the effectiveness of pharmacologic and nonpharmacologic management to relieve breathlessness in patients with advanced cancer.

Older reviews were excluded.

Volume of studies retrieved, methods of study evaluation, and specific information about studies retrieved were not provided. Authors reviewed articles they deemed important to the science of dyspnea in patients with cancer and its management from the perspective of content experts.

The sample characteristics were not described.

• Listening to the patient and caregiver’s experience with dyspnea and creating an individualized breathlessness plan may be helpful in alleviating anxiety-related dyspnea.
• A fan directed at the face is inexpensive and showed efficacy in one study and may be ideal to manage a breathlessness crisis.
• Relaxation and diaphragmatic breathing techniques may aid in breathlessness and anxiety.
• Noninvasive ventilation may have a role in dyspnea symptom control in select patients but has been ill-defined.
• Safety of using opioids across populations of breathless patients with cancer needs to be tested by adequately powered epidemiologic studies.
• No controlled trials support use of phenothiazines or benzodiazepines for management of breathlessness, but authors suggest use of these agents as adjuncts to other therapies or when symptoms are refractory to other therapies.
• A fully powered multi-center randomized controlled international study is underway to test the efficacy of oxygen in reducing dyspnea.
• Heliox is best used after therapies have been rigorously applied and failed to elicit reduction in dyspnea.
• The use of antidepressants or inhaled furosemide for breathlessness in patients with advanced cancer requires systematic investigation.

Progression of the science of understanding breathlessness in patients with cancer requires collaboration between the research and clinical practice of cardiology, oncology, palliative medicine, social sciences, and physiology. Because dyspnea is a dynamic process that may manifest differently in unique populations and situations, possible variables should be well delineated and interventions should be varied to learn the most information about management of this complex symptom.

This review provides a summary of the evidence in multiple interventions, but the report is limited due to lack of provision of study sample characteristics and information regarding the search strategy and methods of evaluation of the strength of the evidence. These limit the level of confidence in findings and conclusions.

The first step to managing breathlessness is careful assessment of the patient and investigation of potential correctable etiologies of breathlessness. The interview should include a patient and caregiver accounting the dyspnea and its triggers, intensity, aggravating factors, alleviating factors, and response to pharmacologic and nonpharmacologic interventions.

Oxygen and air were administered via nasal cannula at 4 liters per minute for 15 minutes to hospice patients reporting dyspnea at rest. Order of treatment was randomly determined.

The study reported on a sample of 38 patients. Forty-five patients were entered into the study, but two were excluded because of equipment failure, one becuase of cough, and four because they did not understand the use of VAS and Borg scales.

The mean age was 71 years, with a range of 54–90 years.

Sixteen patients were women, 20 had a primary diagnosis of lung cancer, two had mesothelioma, and the rest had other primary cancers with metastases to the lung. Thirteen patients had significant chronic obstructive pulmonary disease, and four had cardiac disease.

The study was conducted on two inpatient hospice units.

The study was a single-blind, randomized, placebo-controlled trial.

• Vertical 100 mm VAS
• Modified Borg Scale
• Oxygen saturation percentage via pulse oximeter
• Measurements were taken pretreatment and again after 15 minutes of each test gas.

No significant difference in mean baseline score for VAS was observed for those receiving air first versus those receiving oxygen first.

Mean baseline VAS levels (on room air 59 mm) were significantly reduced after administration of either air (48 mm, p = < 0.001) or oxygen (45 mm, p = < 0.001).

No statistically significant difference was noted in order of treatment effect. No difference in the response to oxygen or air in patients with history of cardiopulmonary disease was observed, and the improvement in dyspnea with oxygen could not be predicted from a subject’s initial level of hypoxia.

No correlation was found between the effect of oxygen on dyspnea and oxygen saturation while on air; oxygen administration corrected hypoxemia when present.

In a qualitative subset of 28

• after oxygen, 15 reported improvement and 2 felt worse
• after air, 11 felt better and 3 felt worse.

The VAS score changed significantly from baseline with both oxygen and air in the subgroup of patients who were receiving morphine plus benzodiazepine compared to subgroups receiving morphine alone, benzodiazepine alone, or neither morphine nor benzodiazepine.

Both oxygen and air can have a significant effect in reducing dyspnea at rest in persons with advanced cancer.

The sample size was small but larger than most dyspnea studies. There was no formal washout period between the two test gases, so there may have been a carryover effect in those who received the oxygen first. Comparison of subgroups of patients on drug therapy was based on very limited numbers of subjects, and the authors' conclusion regarding usefulness of benzodiazepines to potentiate effect of oxygen is taken with caution and should be redemonstrated with a larger number of subjects.

Findings are different than the Bruera et al. (1993) study regarding the beneficial effect of oxygen for hypoxic patients.

To test the safety and efficacy of biosimilar granulocyte–colony-stimulating factor (G-CSFs) filgrastim as prophylactic treatment for the reduction of severe chemotherapy-induced neutropenia in patients undergoing treatment for early and advanced soft-tissue sarcoma with anthracycline and ifosfamide–based chemotherapy

G-CSFs were administered in one of three forms (biosimilar filgrastim, originator filgrastim, or lenograstim) as primary prophylactic treatment for patients with a 20% or greater risk for febrile neutropenia per the European Organization for Research and Treatment of Cancer's (EORTC's) clinical guidelines based on the administration of epirubicin and ifosfamide (EI) treatment for soft-tissue sarcomas.

• N = 67   
• MEDIAN AGE = 60 years
• AGE RANGE = 28–78 years
• MALES: 41.8%, FEMALES: 58.2%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Soft-tissue sarcoma, primary or metastatic
• OTHER KEY SAMPLE CHARACTERISTICS: Patients treated with EI from 2003–2013 were included in the study.

• SITE: Not stated/unknown   
• SETTING TYPE: Multiple settings    
• LOCATION: Not clearly specified. PI is from a cancer research institute in Italy.

PHASE OF CARE: Active antitumor treatment

Retrospective analyses

Outcome measures included overall survival, neutropenia, and sepsis. A cost analysis was also conducted. Dependent variables included patient demographic information (age, sex, body mass index, and setting) and type of G-CSF administered.

No statistically significant differences were found between the administration of biosimilar filgrastim, originator filgrastim, or lenograstim for the outcome variables. A difference existed in the cost-savings model with the cumulative cost of treatment with biosimilar filgrastim (€35.82 on day 3 to €131.34 on day 11) compared to originator filgrastim (€170.97 on day 3 to €626.89 on day 11) and lenograstim (€193.02 on day 3 to €707.74 on day 11). However, statistically significant differences were not reported.

The use of prophylactic biosimilar filgrastim is equally effective yet less expensive than originator filgrastim or lengrastim for overall survival, neutropenia, and sepsis in patients undergoing treatment for early and advanced soft-tissue sarcoma with anthracycline and ifosfamide–based chemotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Findings not generalizable

Understanding that biosimilar filgrastim is equally effective yet more economical than originator filgrastim or lengrastim can help guide treatment decision making for patients with advanced soft-tissue sarcoma at risk for chemotherapy-induced neutropenia.