Pilot evaluation of a stellate ganglion block for the treatment of hot flashes.

PURPOSE: Hot flashes are a significant problem in breast cancer patients, especially because the most effective therapy, estrogen, is often contraindicated. Based on recent pilot data from a single group supporting the use of a stellate ganglion block for the treatment of hot flashes, the present pilot trial was done to further evaluate the hypothesis that a stellate ganglion block may be a safe and effective therapy for hot flashes. METHODS: In women with breast cancer who had hot flashes, a stellate ganglion block was performed after 1 week of baseline hot flash data collection. The main efficacy measures were the changes from baseline in hot flash frequency and hot flash score during the 6th week. RESULTS: Ten patients were enrolled between 4/23/2009 and 7/10/2009; eight patients were evaluable. After the stellate ganglion block, the mean hot flash frequency and score decreased from baseline values by over 60% during some of the post-treatment weeks. The mean hot flash frequency and score at week 6 decreased from baseline values by 44% and 45%, respectively. There were no significant adverse events clearly attributed to the stellate ganglion blocks. CONCLUSIONS: The results of this pilot trial support that stellate ganglion blocks may be a helpful therapy for hot flashes. A prospective placebo-controlled clinical trial should be done to more definitively determine this contention.

Sternal skin conductance: a reasonable surrogate for hot flash measurement?

OBJECTIVE: This study aims to examine the accuracy of a new sternal skin conductance (SSC) device in measuring hot flashes and to assess the acceptability of the device by women. METHODS: Three small descriptive pilot studies were performed using two sequential prototypes of the SSC device developed by an engineering device company in the Midwest. The devices were worn either in a monitored setting for 24 hours or in an ambulatory setting for 5 weeks. During the study period, women recorded hot flashes in a prospective hot flash diary and answered questions about the acceptability of wearing the SSC device. RESULTS: The first prototype was not able to collect any analyzable skin conductance data owing to various malfunction issues, including poor conductance and battery failure. However, 16 women wore the device for 5 weeks and reported that wearing the device was acceptable, although 31% stated that it interfered with daily activities. Hot flash data from the second prototype revealed a 24% concordance rate between self-reported and device-recorded hot flashes. CONCLUSIONS: Findings from these studies support discordance between device-recorded and self-reported hot flashes. In addition, the studies reveal further limitations of SSC monitoring, including difficulties with data collection and lack of consistency in interpretation. Based on these results and other recent trials identifying issues with SSC methodology, it is time to find a better physiologic surrogate measure for hot flashes.

Wisconsin Ginseng (Panax quinquefolius) to improve cancer-related fatigue: a randomized, double-blind trial, N07C2.

BACKGROUND: Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF. METHODS: A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) provider grading. RESULTS: Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] = 27.1) in the ginseng arm vs 8.2 (SD = 24.8) in the placebo arm at 4 weeks (P = .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD = 27) for the ginseng group and 10.3 (SD = 26.1) for the placebo group (P = .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms. CONCLUSIONS: Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.

Paced breathing compared with usual breathing for hot flashes.

OBJECTIVE: Paced breathing (slow, deep, diaphragmatic breathing) reduces central sympathetic activity and facilitates the relaxation response. The present study was designed to assess the feasibility of and to obtain initial efficacy estimates of two paced-breathing programs, compared with usual breathing, for the frequency and severity of hot flashes. METHODS: We designed a 9-week, randomized, three-arm, parallel-group, blinded (investigator) phase II clinical trial. Using an audio CD, participants in the active arms practiced paced breathing at 6 breaths/minute for 15 minutes, either once or twice a day, whereas the control arm practiced usual breathing at 14 breaths/minute for 10 minutes/day. Feasibility was assessed through self-report questionnaires; percent reduction and effect size estimates were determined using changes in hot flash frequency and scores within each group. RESULTS: Of the 92 eligible participants, 68 (74%) completed the study. Most women reported that the intervention was easy to do (79%) and of appropriate duration (71%). They could practice exercises as taught (61%) and could practice on most days (65%). Participants in all arms reported hot flash reductions during the 9 weeks: 52% for paced breathing twice a day, 42% for paced breathing once a day, and 46% for usual breathing. CONCLUSIONS: The paced-breathing intervention is feasible. Although paced breathing twice a day seems to be the most helpful dose, efforts to intensify paced breathing once a day may be more practical for widespread dissemination. The efficacy and overall clinical impact of paced-breathing exercises on hot flash reduction require further evaluation in an adequately powered, placebo-controlled, randomized phase III clinical trial.

Antiemetics for chemotherapy-induced nausea and vomiting occurring despite prophylactic antiemetic therapy.

BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect. Previous studies have primarily focused on prophylactic therapy, but no published reports have evaluated the treatment of breakthrough CINV. METHODS: A prospective, pilot study was performed to provide preliminary prospective evidence of the efficacy of individual agents prescribed for the treatment of breakthrough CINV. Enrolled patients were receiving moderately or highly emetogenic chemotherapy and prophylactic treatment of CINV based on antiemetic guidelines. Patients were prescribed an antiemetic for breakthrough CINV at the discretion of their treating oncologist. If patients had breakthrough CINV that required a breakthrough antiemetic medication, they were instructed to complete a questionnaire every 30 minutes for 4 hours after taking the antiemetic. Levels of nausea (0-10), vomiting, and side effects were recorded. RESULTS: Of the 96 patients enrolled, 27 (28%) reported breakthrough nausea and/or vomiting requiring medication and completed the questionniare. Eighty-eight percent (n = 24) reported the use of prochlorperazine; they experienced a 75% median nausea reduction after 4 hours, with minimal side effects. Three patients (12%) reported the use of a 5-hydroxytryptophan (5-HT) receptor antagonist for treatment of breakthrough nausea. These patients reported a median nausea reduction of 75% after 4 hours and no perceived toxicities. CONCLUSIONS: Prochlorperazine and 5-HT receptor antagonists appear to be effective breakthrough antiemetic therapies. The described study methodology can be used to conduct randomized clinical trials to find more effective drugs for treating established nausea.