Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy
Chemotherapy is used as an adjuvant treatment for breast cancer, like hormone therapy in
patients with hormone-sensitive breast cancer or immunotherapy in those with Human Epidermal
growth factor Receptor 2 (HER2)-overexpressing cancer.
These adjuvant treatments reduce the risk of recurrence and metastasis. The side effects of
hormone therapy are known and depend on the therapeutic strategy and the drugs used. The
side effects of Tamoxifen are similar to menopausal symptoms: hot flashes (half of the
female population), vaginal dryness or leukorrhea, nausea, irregular menstruation, benign
ovarian cyst and, less frequently, weight gain. Aromatase inhibitors have the same side
effects, though with lesser frequency and intensity. The incidence rate of hot flashes after
adjuvant treatment in menopausal women with localized breast cancer is 60 to 65 %, and these
reactions are very severe in one third of these women. Despite this fact, the management of
hot flashes is not systematic and there is currently no therapeutic strategy with proven
efficiency. BRN01 (Boiron laboratory) is a homeopathic remedy whose active ingredient is
already present in other homeopathic drugs indicated for the management of menopausal hot
flashes. BRN01 could reduce the intensity of the reaction in women with breast cancer
receiving adjuvant hormonal treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
The hot flash score is equal to: (number of hot flashes/day) x (mean intensity/day). Treatment efficiency scores will be calculated as follows: (hot flash score on the 4th week of the second period)-(hot flash score on the 2nd week of the first period). Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).
The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 4th week of the second period (placebo or BRN01).
Jean-Paul Guastalla, MD
Centre Leon Berard, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)