Gupta, S., Singh, P.K., Bhatt, M.L., Pant, M.C., Gupta, R., & Negi, M.P. (2010). Efficacy of granulocyte colony stimulating factor as a secondary prophylaxis along with full-dose chemotherapy following a prior cycle of febrile neutropenia. Bioscience Trends, 4, 273–278.
The purpose of the study was to evaluate the feasibility and efficacy of G-CSF secondary prophylaxis in patients with solid tumors undergoing chemotherapy.
Patients in the study required IV antibiotics filgrastim 300 mg per day subcutaneously starting 24–30 hours after the last chemotherapy dose in a subsequent cycle. A total of 8–9 alternate day doses were given. If no other dose limiting toxicity was seen, patients received full chemotherapy dosing with filgrastim support for following treatment cycles. Duration of hospital stay, days on antibiotic therapy, incidence of fever, time to resolve fever, dose reductions or delays, neutrophil recovery time, and incidence of adverse events were recorded. Results compared to findings in the same patients during the previous chemotherapy cycle.
Single-site location in India
Active antitumor treatment
Prospective, single group, observational study
No specific measure definitions were provided.
Neutrophil recovery time, duration of fever, duration of antibiotics and duration of hospitalization, cycle delays, and chemotherapy dose reductions declined with each course of chemotherapy. The decrease in all measures was significant across four treatment cycles (p < 0.01).
Study findings provide some support the use of colony-stimulating factor as secondary prophylaxis in patients receiving myelosuppressive chemotherapy. A number of study limitations limit the strength of these findings.
This study provides limited evidence supporting the use of colony-stimulating factors as secondary prophylaxis in patients receiving chemotherapy. CSF was given every other day in this trial, adding to the body of evidence in which the frequency of administration varies. Secondary prophylaxis can play an important role in sustaining the treatment dosages of chemotherapy cycles.
Guo, Y., Jones, D., Palmer, J.L., Forman, A., Dakhil, S.R., Velasco, M.R., . . . Fisch, M.J. (2014). Oral alpha-lipoic acid to prevent chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled trial. Supportive Care in Cancer, 22, 1223–1231.
To test whether oral alpha-lipoic acid (ALA) could reduce the severity of peripheral neuropathy in patients receiving platinum-based chemotherapy
Prior to randomization, patients were stratified according to prior exposure to platinum-based therapy dosages. Patients were assigned to receive ALA 600 mg oral sustained-release tablets three times per day. Control patients received a matching placebo. Medications were taken continuously for 24 weeks between two days prior and four days after each dose of platinum.
Only 28% in the ALA arm and 30% in the placebo arm completed 24 weeks of the study. Most discontinued the study because of withdrawal of consent and noncompliance. Neuropathy scores increased significantly from baseline in both groups at 24 weeks (p < .001). No differences were observed in study results between groups. Authors state that attrition was not related to toxicities and that adverse events were comparable between groups.
Findings did not show a beneficial effect of ALA for prevention or reduction of peripheral neuropathy in patients receiving platinum-based chemotherapy.
Findings do not show a benefit of oral ALA for prevention of chemotherapy-induced peripheral neuropathy with platinum-based chemotherapy. Management and prevention of chemotherapy-induced peripheral neuropathy is a challenge that is generally managed by dose reduction or chemotherapy discontinuation, which can reduce effectiveness in treatment of cancer. Few approaches have shown to be effective in preventing or reducing chemotherapy-induced peripheral neuropathy. Ongoing research in this area is needed.
Guo, S.P., Wu, S.G., Zhou, J., Feng, H.X., Li, F.Y., Wu, Y.J., . . . He, Z.Y. (2014). Transdermal fentanyl for pain due to chemoradiotherapy-induced oral mucositis in nasopharyngeal cancer patients: Evaluating efficacy, safety, and improvement in quality of life. Drug Design, Development and Therapy, 8, 497.
To evaluate the safety and efficacy of transdermal fentanyl for oral mucositis pain
Transdermal fentanyl was given at a rate of 25 mcg per hour to patients with pain scores greater than five during treatment and increased by 25 mcg per hour to maintain pain scores less than or equal to three on a numeric rating scale. Study assessments were done on days 1, 4, 7, and 10. Patients rated pain daily.
PHASE OF CARE: Active antitumor treatment
Open-label, observational trial
Mean pain scores declined from 7.41 before treatment to 5.54 (SD = 0.86, p < 0.001) on day 1 and 2.82 (SD = 0.68, p < 0.001) on day 10. Sleep quality was improved after treatment (p < 0.001). The most frequent side effect was nausea and vomiting. No patients discontinued treatment.
Transdermal fentanyl was quickly effective in reducing pain from oral mucositis in this patient population. Pain reduction was associated with improved sleep.
The findings of this study demonstrated that transdermal fentanyl was effective in reducing oral mucositis-related pain within one day, and pain scores continued to decline during combined radiation and chemotherapy. They also suggested that adequate pain control in this patient population improves sleep quality and other aspects of quality of life.
Guo, Z., Tang, H.Y., Li, H., Tan, S.K., Feng, K.H., Huang, Y.C., . . . Jiang, W. (2013). The benefits of psychosocial interventions for cancer patients undergoing radiotherapy. Health and Quality of Life Outcomes, 11, 121.
Many patients with cancer experience depression and anxiety, with an associated decrease in quality of life, during radiation therapy. The main objective of the study was to determine the benefits of psychosocial interventions for these patients with cancer, concurrent with radiation therapy.
Patients in the intervention group received psychosocial care, which consisted of psychoeducation, cognitive behavioral therapy (CBT), and supportive expressive therapy.
Patients were randomized to the intervention arm (psychoeducation, CBT, and supportive expressive therapy) or to the control arm. The control group received radiation therapy only.
An association also was made between intervention and survival.
Patients in the intervention group showed significant improvements in symptoms of depression and anxiety and health-related quality of life. They had better global health status and physical and emotional functioning and less insomnia. No difference was observed between groups in disease-free survival and overall survival.
Psychosocial interventions appear to be a cost-effective approach that can improve a patient’s mood and quality of life during and after radiation therapy.
Chinese study (possible cultural implications)
This is an important study for oncology nurses, especially radiation therapy oncology nurses, who often feel like they cannot make much impact on their patients' lives, except for checking for toxicities. Nurses have an important role in psychoeducational and supportive therapies. Some very brief strategies being taught regarding CBT and supportive expressive therapy could go a long way in helping many patients.
Gulluoglu, B.M., Guler, S.A., Ugurlu, M.U., & Culha, G. (2013). Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: A randomized controlled trial. Annals of Surgery, 257, 37–43.
To assess the effectiveness of prophylactic antibiotics on prevention of surgical site infection (SSI) and the cost of this effectiveness, as compared to a control without prophylaxis antibiotics in early breast cancer surgery in overweight or obese women
Women randomly were assigned to receive IV infusion of 1 g ampicillin-sulbactam at the start of anesthesia or no prophylactic antibiotics. Patients were followed for 30 days. Outcomes also were compared to a group of women who had a body mass index (BMI) lower than 25 and who did not receive antibiotic prophylaxis.
Nine SSIs developed in the prophylaxis group, versus 25 in the control group (p = .002). Patients were matched well according to age, BMI, history of smoking, ASA class, interval between tissue biopsy and randomization, clinical cancer stage, type of breast and axillary surgery, operation time, hospital stay, and post-operation complications. All SSIs were discovered within post-operation week one after discharge, except one. The control group had significantly more SSIs compared to those in the normal-weight comparison group (p = .0007) and higher SSI treatment costs than the prophylaxis group (p = .007). Patients in the control group had more open surgical biopsies than those in the prophylaxis group (p = .004)
The administration of antibiotics at the time of induction for surgery was associated with reduced incidence of SSI among obese women undergoing breast cancer surgery. Costs were lower among those receiving prophylactic antibiotics.
Reminding physicians to prescribe pre-operation antibiotics is important. Administration of a dose of IV antibiotics at the time of induction is a current U.S. standard of care and recommendation for SSI prevention. Careful hand washing and clean dressing changes are imperative. These findings also point to the increased risk of infection associated with obesity. Nurses can educate patients regarding risks associated with obesity and assist patients with weight management.
Gujral, M. S., Patnaik, P. M., Kaul, R., Parikh, H. K., Conradt, C., Tamhankar, C. P., & Daftary, G. V. (2001). Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers. Cancer Chemotherapy and Pharmacology, 47, S23–S28.
To determine the effect of oral proteolytic enzymes for prevention of acute side effects in patients with head and neck cancer.
Patients were randomly assigned to the control or experimental group.
The enzymes taken were a combination of papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg (MUCOS Pharma). Patients took three tablets, three times per day, three days prior to start of radiation therapy (RT), and up to five days after completion.
Mucositis, skin reaction, and dysphagia were graded at each visit during and after RT. Scoring was done at baseline, weekly, and five to six months following treatment.
The study was a prospective, randomized, open-label trial.
Oral proteolytic enzymes may be helpful in reducing the severity of radiodermatitis.
Guerreiro Godoy Mde, F., Oliani, A.H., & Pereira de Godoy, J.M. (2010). Active exercises utilizing a facilitating device in the treatment of lymphedema resulting from breast cancer therapy. German Medical Science: GMS e-Journal, 8, Doc31.
To determine the effectiveness of an assistive mobile flexion bar during exercise to reduce arm volume in patients diagnosed with lymphedema related to breast cancer treatment
Participants were randomly selected, and all participants received the intervention. Participants received a single one hour of active exercising split into 12-minute sections with 3 minutes of flexion bar use between each section. The flexion bar is a T-shaped apparatus, the vertical bar remains fixed (10 cm away from the patient on a tabletop), and the horizontal bar rotates (30 cm above the tabletop) to allow extension and flexion of arm muscles. All of the participants wore a compression sleeve on the affected limb. The participants independently performed the exercise routine, and the sole purpose of the interventionist was to control the time of exercise intervals and to help participants maintain proper posture and spinal alignment.
The study took place at a rehabilitation facility in Brazil.
Patients were undergoing active lymphedema treatment.
The study used a prospective trial design.
The participants initial mean volume was 2,089.9 ml. After the exercise session, the mean final volume decreased to 2,023.0 ml. The study used a paired t-test with an alpha error of 5% as acceptable. The results concluded in a mean loss of 66.9 ml (p < 0.001). There was a significant reduction in limb volume, using active exercises with a facilitating device (mobile flexion bar).
The trial suggests that the use of an apparatus mobile flexion bar may improve the efficacy of lymphedema reduction by myolymphokinetic exercises. Active exercises are beneficial to patients with lymphedema because it promotes muscle contraction and lymphatic drainage. The study has its risks for bias based on the small sample size and the lack of a control group.
Because of the statistical significance of the findings of the study, it is important for nurse researchers to repeat the study using a more rigorous study design. If the experiment were repeated as a randomized controlled trial with a larger sample size, the results would be more generalizable. It would also be interesting to compare the use of a mobile flexion bar to active exercise without the use of a facilitating device to determine the necessity.
Guan, J., Tanaka, S., & Kawakami, K. (2015). Anticonvulsants or antidepressants in combination pharmacotherapy for treatment of neuropathic pain in cancer patients: A systematic review and meta-analysis. Clinical Journal of Pain, 32, 719–725.
STUDY PURPOSE: To investigate the efficacy of antidepressants and anticonvulsants in combination therapy for neuropathic pain in patients with cancer
TYPE OF STUDY: Meta-analysis and systematic review
PHASE OF CARE: Multiple phases of care
APPLICATIONS: Palliative care
When both types of interventions were considered, use of these adjuvant medications in combination pharmacotherapy was superior to control regimens (p < 0.010, MD = -0.41). However, in subgroup analysis, anticonvulsants (MD = -0.12, 95% CI [-0.64, 0.39]) did not show a significant effect. Antidepressants showed some efficacy (MD = -0.54, 95% CI [-0.94, -0.12]) based on only two studies. Anticonvulsants showed better efficacy among studies including only chemotherapy-induced neuropathic pain. Withdrawals in experimental groups was two times higher than in control groups. Study duration ranged from 10 days to 6 weeks.
Use of adjuvant antidepressants and anticonvulsants had a significant but small effect on neuropathic pain, and anticonvulsants considered alone showed no overall significant effectiveness. Evidence was too limited to formulate a recommendation for use.
There is limited evidence to demonstrate effectiveness of anticonvulsants or antidepressants as adjuvant medications for neuropathic pain management, and high withdrawal rates in studies within groups receiving these drugs may point to their potential side effects. Nurses need to be aware of and monitor the adverse side effects of these medications.
Gruschkus, S.K., Lairson, D., Dunn, J.K., Risser, J., & Du, X.L. (2010). Comparative effectiveness of white blood cell growth factors on neutropenia, infection, and survival in older people with non-Hodgkin's lymphoma treated with chemotherapy. Journal of the American Geriatrics Society, 58, 1885–1895.
To examine the effect of colony-stimulating factors (CSFs) used as primary and secondary prophylaxis on incidence of febrile neutropenia, infection, and survival in older adults.
The study used data from the Surveillance, Epidemiology, and End Results (SEER) Medicare database. ICD-9 codes were used to define inclusion diagnoses and definition of febrile neutropenia.
Use of CSF, the type of chemotherapy administered, and the use of antibiotics were defined in terms of CPT codes. Regression analysis was used to analyze effects of primary and secondary CSF prophylaxis on outcomes of interest. Primary prophylaxis was defined as CSF during chemotherapy before occurrence of fever, infection, or neutropenia. Secondary prophylaxis was CSF administration that occurred after these events. Study used data from 1992–2002.
Multi-site (SEER data)
There were mutliple phases of care
Application is for elder care
Retrospective cohort study
Sixty percent of cases did not receive any CSF. Those who had 5–9 CSF administrations for primary prophylaxis has a 42% lower risk of febrile neutropenia (OR = 0.58, 95% confidence interval [CI] [0.41, 0.83]) and those with 10 or more administrations had a 48% lower risk after data were adjusted for age, marital status, stage, and other characteristics. Those with 5–9 administrations had a 27% lower incidence of infection, and those with 10 or more administrations had a 52% lower risk (OR = 0.48, 95% CI [0.35, 0.66]). Primary prophylactic CSF was not associated with longer overall survival. Secondary prophylaxis was associated with improved overall survival, with a strong dose-response effect. A range of 11–23 administrations was associated with a 23% lower risk of mortality (HR = 0.77, 95% CI [0.71, 0.84]), and those with more than 23 administrations had a 13% lower risk of mortality than others. Protective effects of primary prophylaxis was highest in those receiving the largest number of chemotherapy administrations and in those with large B-cell lymphoma.
Primary prophylaxis with CSF in older adults is effective in preventing febrile neutropenia and infection, but was not associated with improved survival. Secondary prophylaxis was associated with longer overall survival.
Findings support the use of primary prophylactic CSF for prevention of infection and febrile neutropenia, and secondary prophylaxis in improving survival in this group of patients. Limitation of retrospective statistical analysis using medical records code data only need to be considered in interpretation and application of these results.
Grunwald, V., Kalanovic, D., & Merseburger, A.S. (2010). Management of sunitinib-related adverse events: An evidence- and expert-based consensus approach. World Journal of Urology, 28, 343–351.
To provide advice for patient care in daily practice regarding the management of side effects of sunitinib.
Information was compiled and clinical experts were asked to identify the degree to which they agreed or disagreed with the information. Those measures agreed on by 70% of respondents were included in this summary. Clinicians had to have cared for at least 30 patients receiving sunitinib. Twelve German clinical experts provided analysis.
Databases searched were PubMed, Embase, Current Contents, and recommendations of oncology societies.
Key topics were sunitinib and tyrosine kinase inhibitor therapy management recommendations.
Arterial Hypertension:
Fatigue:
Mucositis/Oral Disorders:
Diarrhea:
Nausea and Vomiting:
Skin Reactions
Hand-Foot Syndrome:
Erythema, Dry Skin, and Dermatitis:
A significant need exists for more scientific evidence on the prevention and management of side effects caused by these agents for cancer treatment.