Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer (HBC)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Adjuvant hormonal therapy, Homeopathic treatment, Hot flashes, Quality of life, Hot flash score
Eligibility Criteria
Inclusion Criteria:
- Female patient aged ≥ 18 years
- Women with histologically proven non metastatic breast cancer
- ECOG PS ≤ 1
- Patient receiving adjuvant hormonal therapy for at least 1 month (aromatase inhibitor or Tamoxifen ± ovarian function suppression (Luteinizing Hormone Releasing Hormone agonist (LH-RH agonist), ovariectomy...))
- Patient complaining of hot flashes with moderate to severe intensity, affecting quality of life, for at least 1 month before inclusion
- Patient agreement not to start another hot flash treatment during the study (allopathic treatment, E vitamin, dietary supplement, phytotherapy, acupuncture...)
- Patient able to understand, read and write French
- Mandatory affiliation with a health insurance system
- Signed, written informed consent
Exclusion Criteria:
- Ongoing chemotherapy or radiotherapy, or treatment planned to begin during the study
- Patient with a condition known to induce hot flashes such as hyperthyroidism, diabetes, adrenal tumor, enteric carcinoid tumor, mastocytosis...
- Patient with severe renal failure, severe hepatic failure, or cardiovascular disease
Patient with one of the following contraindications:
- known hypersensitivity to one of the components of the study drug
- galactose, fructose intolerance
- Lapp lactase deficiency, isomaltase invertase deficiency
- Glucose or galactose malabsorption syndrome
- Follow up impossible because of social, familial, geographical or psychological reasons
- Patient suspected of poor compliance with protocol or treatment
- Participation in another biomedical research trial in the same indication, or administration of an experimental drug in the same indication in the 30 days before inclusion
Sites / Locations
- Centre Hospitalier de Chambery
- Centre Jean Perrin
- Centre Leon Berard
- Centre Hospitalier de Montelimar
- Centre Hospitalier d'Annecy
- Centre Hospitalier de Roanne
- Clinique Armoricaine de radiologie
- Institut de Cancérologie Lucien Neuwirth
- Centre Hospitalier de Valence
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
BRN01
Placebo
A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms: Experimental: BRN01 Placebo Comparator: Placebo
A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms: Experimental: BRN01 Placebo Comparator: Placebo