Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women

Breast cancer is the second most frequent cancer worldwide, and the most frequent in France. Principal therapy consists in radiotherapy, that is locoregional, using radiations to kill cancerous cells.

Radiotherapy has sides effects as radiodermatitis, concerning about 90 percent of women treated. Radiodermatitis could be described with three factors : redness, heat, and edema.

Risk of flushing could be reduced by hygienic rules concerning hydratation, clothes, and toilet.

Nowadays, no treatment proved homeopathic efficacy to prevent radiodermatitis. This treatment is popular but also contested. No clinical trial proved its efficacy for this indication. The present study aims at evaluating Radium bromatum efficacy (homeopathy), compared to placebo, to prevent radiodermatitis apparition for women treated for breast cancer.

Inclusion criteria

• Major patient;
• Indication of curative intent radiotherapy for breast cancer treated with conservative treatment. Accepted radiotherapy scheme: 50 Gy (main) + 16 Gy on the tumor bed (additional dose);
• Patient affiliated or entitled to a social security scheme;
• Patient who signed an informed consent form.

Exclusion criteria

• Pregnant or lactating woman;
• Legal incapacity or limited legal capacity. Medical or psychological conditions that do not allow the subject to understand the study and sign the consent
• Patient followed by a liberal homeopath;
• Patient with bilateral breast cancer;
• Patient with in situ breast cancer;
• Patient with known cognitive impairment;
• Patient with known allergy and / or intolerance and / or malabsorption to fructose, glucose, galactose;
• Patient with a known deficiency in sucrase / isomaltase / lactase.