Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Leon Berard
• Collaborator: BOIRON

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