Barton, D.L., LaVasseur, B.I., Sloan, J.A., Stawis, A.N., Flynn, K.A., Dyar, M., ... & Loprinzi, C.L. (2010). Phase III, placebo-controlled trial of three doses of citalopram for the treatment of hot flashes: NCCTG trial N05C9. Journal of Clinical Oncology, 28, 3278-3283.
To evaluate three different doses of citalopram for management of hot flashes
Women were randomly assigned to receive 10, 20, or 30 mg citalopram or corresponding number of placebo pills daily for six weeks. Treatment was titrated weekly to achieve the target dose.
Placebo controlled RCT
There was some improvement in hot flash interference with several areas, and those on 20 and 30 mg of citalopram had significant improvement in sleep interference compared to placebo (p ≤ .01). There were no group differences in overall POMS scores. Adverse effects on sexual health were greater with 30 mg compared to placebo, but this difference was not statistically significant.
Findings show that citalopram in a dose as low as 10 mg daily can significantly improve hot flash symptoms and is not associated with toxicity. Further benefits were seen with higher doses.
Findings show that citalopram was beneficial to reduce hot flash severity. The duration of treatment in this study was only six weeks, so longer term efficacy is not clear. Patients on any longer term management with citalopram need to be monitored for side effects of the medication.
Barton, D.L., Liu, H., Dakhil, S.R., Linquist, B., Sloan, J.A., Nichols, C.R., . . . Loprinzi, C.L. (2013). Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2. Journal of the National Cancer Institute, 105, 1230–1238.
To evaluate the efficacy of Wisconsin ginseng on cancer-related fatigue (CRF).
2,000 mg of Wisconsin ginseng or placebo BID (breakfast and lunch) over eight weeks. The assessment conducted at baseline and at four and eight weeks.
Statistically significant changes in scores for MFSI-SF between ginseng and placebo groups at four and eight weeks was in favor of ginseng, but only among those in active treatment. No differences in BFI scores were noted. Greater benefit reported among patients receiving active cancer treatment versus those who had completed treatment.
The ginseng group had improvements in fatigue scores over four- and eight-week periods without significant toxicities. However, data lacking on selected drug-ginseng interactions.
Supports use of (controlled, manufactured) Wisconsin ginseng to modify CRF; however, more research is needed to determine how to maximize positive effects. It appears that ginseng effects may only be seen during active treatment.
Barton, D.L., Burger, K., Novotny, P.J., Fitch, T. R., Kohli, S., Soori, G., . . . Loprinzi, C.L. (2013). The use of ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9. Supportive Care in Cancer, 21, 1185–1192.
Evaluate ginkgo biloba for the prevention of cognitive decline associated with adjuvant treatment for breast cancer
Patients were randomized to receive 60 mg of ginkgo biloba or a matching placebo twice a day starting before the second cycle of thermotherapy and continuing throughout treatment and 1 month beyond chemotherapy completion. Participants were stratified by type of chemotherapy, age, menopausal status, and lymph node involvement. Data were collected at baseline before the first or second chemotherapy cycle, during chemotherapy, at the first visit after chemotherapy (1 month), and at 6, 12, 18, and 24 months post-chemotherapy.
Participants were receiving active antitumor treatment.
Double-blind, randomized, placebo-controlled study
No significant differences were seen between groups over 24 months in any study measures. All cognitive test scores improved from baseline to the first chemotherapy follow-up and then stabilized.
The study does not support the use of ginkgo biloba for prevention of cognitive impairment resulting from chemotherapy treatment in women with breast cancer.
Findings do not support the use of ginkgo biloba to prevent cognitive changes resulting from chemotherapy in patients with breast cancer.
Barton, D.L., Thanarajasingam, G., Sloan, J.A., Diekmann, B., Fuloria, J., Kottschade, L.A., . . . Loprinzi, C.L. (2014). Phase III double-blind, placebo-controlled study of gabapentin for the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, NCCTG N08C3 (Alliance). Cancer, 120, 3575–3583.
To compare gabapentin to a placebo on three factors: efficacy in decreasing CINV, tolerability to the medication, and impact on quality of life.
This phase 3 study was a placebo-controlled trial that was randomized and double-blinded.
This study did not support the effectiveness of gabapentin as prophylaxis for delayed chemotherapy-induced nausea and vomiting when used in conjunction with dexamethasone and a 5HT3 receptor antagonist.
Based on this study, gabapentin is not recommended as prophylaxis for delayed chemotherapy-induced nausea and vomiting.
Barton, D. L., Soori, G. S., Bauer, B. A., Sloan, J. A., Johnson, P. A., Figueras, C., . . . Loprinzi, C. L. (2010). Pilot study of Panax quinquefolius (American ginseng) to improve cancer-related fatigue: a randomized, double-blind, dose-finding evaluation: NCCTG trial N03CA. Supportive Care in Cancer, 18, 179–187.
To determine whether any of three specific doses of American ginseng help cancer-related fatigue, as well as to evaluate toxicity.
Patients were randomized to receive ginseng doses of 750, 1,000, or 2,000 mg per day or placebo. Doses were given in twice daily dosing over eight weeks. The ginseng used was Wisconsin ginseng that met quality-control requirements for pesticides and contaminants. Specific description of ginsenosides content is described.
Outcome measures were obtained at baseline, four weeks, and eight weeks. Patients were stratified according to stage of disease, gender, baseline fatigue score, and current treatment. Randomization assignments were computer-generated using a dynamic allocation procedure for distribution of stratification factors.
This was a multisite collaborative trial of the North Central Cancer Treatment group and the Mayo Clinic.
This was a randomized, double-blind, placebo-controlled study.
Findings suggest that ginseng at the dose of 750 mg per day did not provide any benefit over that of placebo. At the two highest doses of ginseng, a trend was observed of decreased fatigue compared to placebo.
The preliminary evidence here suggests that the improvement in patient perception with ginseng versus placebo is that this effect may have broad benefit to patients, even if objective measures of outcomes are nonsignificant. It would be worthwhile to more clearly and definitively evaluate the benefits of ginseng in additional larger, more definitive clinical trials.
Barth, J., Delfino, S., & Kunzler, A. (2013). Naturalistic study on the effectiveness of psycho-oncological interventions in cancer patients and their partners. Supportive Care in Cancer, 21, 1587–1595.
To explore the effectiveness of psycho-oncologic interventions for patients and partners on anxiety, depression, psychopathology, and distress
Patients and partners who had been referred for psycho-oncologic service were recruited. Common interventions were psychoeducation, cognitive restructuring, behavior control techniques, guided imagery, relaxation, couples communication training, and other types of counseling in an individualized, nonstandard fashion. Patients and partners were grouped according to propensity scores calculated from variables shown to be significant in regression analysis for outcomes of interest, including gender, age, cancer site, stage of disease, baseline anxiety, and depression. Propensity matched control patients, and partners who did not receive the intervention were identified and used as control comparisons. Analysis was done in groupings according to the level of distress with propensity scores as low-, moderate-, or high-distress.
Time effects within patient groups showed significant decreases over time in depression and distress (p ≤ .05), but not for anxiety and psychopathology. No group effects were seen on outcomes over time. Among partners, no changes were seen over time and no significant effects of the intervention were seen on outcomes. The same pattern was seen in completer and intent to treat analysis. Pre- and post-intervention data showed that patients had significant declines in anxiety (effect size Cohen’s d = 0.32, p = .01), distress (d = .46, p = .001), and depression (d = 0.52, p = .001) at 12 months, and partners had significant declines in anxiety (d = 0.45, p = .01) and distress (d = .42, p = .02) within the highly distressed group. No significant differences were seen in the less distressed group over time.
Findings suggest that psychotherapeutic interventions can reduce anxiety, distress, and depression among patients and partners who are highly distressed. Little benefit may exist for individuals who are less anxious or distressed at baseline.
Psychotherapeutic interventions may be beneficial for patients and caregivers who are highly distressed. Nurses need to be aware of the overall level of patient and caregiver distress and identify those who are likely to benefit from referral for therapy.
Barsevick, A., Beck, S. L., Dudley, W. N., Wong, B., Berger, A. M., Whitmer, K., . . . Stewart, K. (2010). Efficacy of an intervention for fatigue and sleep disturbance during cancer chemotherapy. Journal of Pain and Symptom Management, 40, 200–216.
To evaluate the efficacy of an energy and sleep enhancement (EASE) intervention to relieve fatigue and sleep disturbance and improve health-related functional status.
One hundred fifty-three individuals receiving chemotherapy were randomized to the EASE intervention and 139 were randomized to an attention control intervention. Participants in each group received three telephone sessions taught by a specially trained oncology nurse and a separate written handbook for each assigned intervention. The EASE intervention was based on the common sense model and involved appraisal and representation of symptoms, with a focus on fatigue and sleep disturbance, including communication of individualized strategies for fatigue management and sleep enhancement. The control intervention focused on information about nutrition and a healthy diet. The primary outcomes of fatigue, sleep disturbance, and functional status were measured before chemotherapy, day 4 after first treatment (baseline), and 43 to 46 or 57 to 60 days later (follow-up), depending on the chemotherapy cycle length. Two secondary outcomes, pain and depression, were chosen for evaluation, but not targeted for the intervention, because of an increasing body of evidence linking them to fatigue.
Patients were undergoing the active treatment phase of care.
This was a randomized, controlled trial using repeated measures and an attention control.
Fatigue and patient-reported sleep disturbance were moderately elevated in both groups at baseline and follow-up. Actigraphy revealed that the total sleep time was almost eight hours, and sleep efficacy was in the normal range of greater than 85% for both groups at both time points. Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in the normal range. The EASE intervention did not improve fatigue, reduce sleep disturbance, or prevent functional decline during chemotherapy. Both the EASE intervention group and the control group had an increase in fatigue and decline in physical functioning over time. ANOVA revealed no statistically significant group-by-time effects for fatigue, sleep disturbance, or functional status. A positive outcome in both groups was a decrease in the average number of nighttime awakenings over time. Unemployed individuals showed greater benefit from the EASE intervention and reported less pain and symptom interference.
In patients with cancer undergoing chemotherapy, the EASE intervention did not significantly improve fatigue, sleep disturbance, or physical functioning compared to the control group. Potential explanations include high variability or floor effect for fatigue, incorrect timing of measures, insufficient amount or dose of the intervention, and confounding effects of gender. Future research should consider screening for symptom severity and tailoring interventions.
Future research directions were clearly described in the study, and practice implications included: many individuals with multiple symptoms during chemotherapy could benefit from effective behavioral interventions conducted over time by skilled nurses. Further research could inform nurses of the most effective management methods to control symptoms.
Barsevick, A. M., Dudley, W., Beck, S., Sweeney, C., Whitmer, K., & Nail, L. (2004). A randomized clinical trial of energy conservation for patients with cancer-related fatigue. Cancer, 100, 1302–1310.
The energy conservation and activity management (ECAM) intervention consisted of information provision, guidance in formulating and implementing a plan for energy conservation and activity management, and support in appraising the effectiveness of symptom management efforts. The intervention included completing a journal to monitor fatigue, sleep, rest, activity, and other symptoms; listing and prioritizing usual activities; and creating a tailored energy conservation plan. The intervention was delivered by nurse counselors in three telephone sessions that were 15 to 30 minutes in length.
Outpatient services of two large university cancer centers
Patients were undergoing the active treatment phase of care.
The study was a randomized, clinical trial with a repeated-measures design and an attentional control group.
Efficacy findings were not confounded by the inability of patients who were in poorer health to complete the data collection process.
Minimal training with the intervention materials is needed.
Barsevick, A. M., Whitmer, K., Sweeney, C., & Nail, L. M. (2002). A pilot study examining energy conservation for cancer treatment-related fatigue. Cancer Nursing, 25, 333–341.
The energy conservation and activity management (ECAM) intervention included completing a journal to monitor fatigue, sleep, rest, activity, and other symptoms; listing and prioritizing usual activities; and creating a tailored energy conservation plan. The intervention was delivered by nurse counselors in three telephone sessions of 15 to 30 minutes in length.
Patients were undergoing the active treatment phase of care.
Profile of Mood States (POMS) Fatigue scale
Minimal training with the intervention materials is needed.
Barsevick, A.M., Sweeney, C., Haney, E., & Chung, E. (2002). A systematic qualitative analysis of psychoeducational interventions for depression in patients with cancer. Oncology Nursing Forum, 29, 73–84.
Databases: CINAHL, MEDLINE, PsycLIT, and CANCERLIT
The study evaluated 36 randomized clinical trials (RCTs), seven quasi-experimental trials, five descriptions, six reviews, and one practice guideline published 1980–2000.
In 22 of 36 RCTS, psychoeducational interventions benefited patients with symptoms of depression.
The evidence dervied from this review supports the benefit of psychoeducational interventions for depression in patients with cancer.