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Brief Title: Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer
Official Title: 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
Study ID: NCT01246427
Brief Summary: The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Centre Hospitalier de Chambery, Chambery, , France
Centre Jean Perrin, Clermont Ferrand, , France
Centre Leon Berard, Lyon, , France
Centre Hospitalier de Montelimar, Montelimar, , France
Centre Hospitalier d'Annecy, Pringy, , France
Centre Hospitalier de Roanne, Roanne, , France
Clinique Armoricaine de radiologie, St Brieuc, , France
Institut de Cancérologie Lucien Neuwirth, St Priest en Jarez, , France
Centre Hospitalier de Valence, Valence, , France
Name: Pierre Etienne Heudel, MD
Affiliation: Centre Leon Berard, France
Role: PRINCIPAL_INVESTIGATOR