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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Radium bromatum/Apis mellifica/Belladonna pills; Drug: Placebo pills of Radium bromatum; Drug: Radium bromatum pills; Drug: Radium bromatum/Apis mellifica/Belladonna placebo pills

• Registration Number: NCT03753776
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-27
• Study Start: 2019-07-15
• Primary Completion: 2024-01-05
• Study Completion: 2024-04-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 232

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radium bromatum/Apis mellifica/Belladonna group	Radium bromatum/Apis mellifica/Belladonna pills	Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis
Radium bromatum placebo group	Placebo pills of Radium bromatum	Placebo group will receive placebo pills of Radium bromatum during radiotherapy
Radium bromatum group	Radium bromatum pills	Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy
Radium bromatum/Apis mellifica/Belladonna placebo group	Radium bromatum/Apis mellifica/Belladonna placebo pills	Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis

Primary Outcome Measures

Name	Time	Method
Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group	Week 6	Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group will be measure with the RTOG (Radiation Therapy Oncology Group) scale. A diminution of 10% between Radium bromatum group and placebo group will be considered as significant

Secondary Outcome Measures

Name	Time	Method
Radiodermatitis frequency	Week 6	Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.
Radiodermatitis delays	Week 6	Radiodermatitis delays will be reported in days.
Pain measure	Week 6	Measure of pain will be reported, calculated with a oral scale between 0 and 10.
Satisfaction measure	Week 6	Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)
Number of concomitant treatments	Week 6	Number of concomitant treatments will be reported.
Level of Quality of life	Week 6	Level of Quality of life will be measured between 0 to 100 with the EQ-5D questionnaire (european quality of life number 5)
Radiodermatitis duration	Week 6	Radiodermatitis duration will be reported in days.

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France