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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Radium bromatum/Apis mellifica/Belladonna placebo pills; Drug: Radium bromatum pills; Drug: Radium bromatum/Apis mellifica/Belladonna pills; Drug: Placebo pills of Radium bromatum

Study type: Interventional

Funder types: Other

Identifiers

NCT03753776

2018-0601

2018-002406-32 (EudraCT Number)

Details and patient eligibility

About

Breast cancer is the second most frequent cancer worldwide. Principal therapy consists in radiotherapy, but this technic has sides effects as radiodermatitis, concerning about 90 percent of women treated.

Risk of flushing could be reduced by hygienic rules, but no treatment proved its efficacy to prevent radiodermatitis.

Homeopathy 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.

Full description

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.

Enrollment: 232 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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232 participants in 4 patient groups, including a placebo group

Radium bromatum placebo group

Placebo Comparator group

Description:

Placebo group will receive placebo pills of Radium bromatum during radiotherapy

Treatment:

Drug: Placebo pills of Radium bromatum

Radium bromatum group

Experimental group

Description:

Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy

Treatment:

Drug: Radium bromatum pills

Radium bromatum/Apis mellifica/Belladonna placebo group

Placebo Comparator group

Description:

Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis

Treatment:

Drug: Radium bromatum/Apis mellifica/Belladonna placebo pills

Radium bromatum/Apis mellifica/Belladonna group

Experimental group

Description:

Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis

Treatment:

Drug: Radium bromatum/Apis mellifica/Belladonna pills