The proposed randomized, placebo-controlled clinical study will examine the use of acupuncture formenopausal symptom management for women who experience menopause following treatment for breast cancer.The study is designed to: 1) Test the anticipated treatment benefits for menopausal symptom reliefusing changes in frequency and severity of hot flashes as outcome measures; 2) Explore the anticipatedtreatment benefits of acupuncture for menopausal symptom relief using changes in severity of moodchanges, sleep disturbances and loss of concentration, and quality of life; 3) Determine the feasibilityof the treatment strategy and develop realistic protocols for women previously diagnosed and treated forbreast cancer by examining recruitment and retention rates and through exit interviews regarding thepotential burden associated with symptom frequency/severity ratings and acupuncture sessions. Athree-group design (site specific needling, control needling, usual care) will be used. Twelveacupuncture treatments will take the form of wither menopausal specific acupuncture sites or controlneedling at acupuncture points identified in the literature as irrelevant to the menopausal symptoms.The non-acupuncture control group will receive usual care with standardized educational sessions ofinformation drawn from published menopausal literature concerning non-hormonal menopausal symptommanagement strategies. The study variables are Menopausal Symptoms with hot flashes (primary marker),mood changes, sleep disturbances and loss of concentration as measured by the daily Symptom Diary andthe modified Kupperman Index; Physiological Measures of menopausal status (serum LH and FSH) and of stressresponse (Cortisol); Quality of Life as measured by the Menopause Specific Quality of Life Questionnaire;and Protocol Design as measured by recruitment and retention rates and exit interviews. A conveniencesample of 81 women who experience menopausal symptoms with one year following treatment for Stage I or IIbreast cancer will be recruited. Data analysis includes descriptive statistics, repeated measures ANOVA,time series analysis, and content analysis. Results from the study will test the effectiveness ofacupuncture as a treatment for menopausal hot flashes and inform the design of a larger, randomized,placebo-controlled clinical trial of acupuncture for menopausal symptom relief.
| Radtke, Jill V; Terhorst, Lauren; Cohen, Susan M (2011) The Menopause-Specific Quality of Life Questionnaire: psychometric evaluation among breast cancer survivors. Menopause 18:289-95 |
| Bender, Catherine M; Ergyn, Fisun Suenuzun; Rosenzweig, Margaret Q et al. (2005) Symptom clusters in breast cancer across 3 phases of the disease. Cancer Nurs 28:219-25 |
