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

NCT ID: NCT03753776

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-15
• Study Completion Date: 2024-04-05

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Radium bromatum placebo group

Placebo group will receive placebo pills of Radium bromatum during radiotherapy

Group Type: PLACEBO_COMPARATOR

Placebo pills of Radium bromatum

Intervention Type: DRUG

Placebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition

Radium bromatum group

Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy

Group Type: EXPERIMENTAL

Radium bromatum pills

Intervention Type: DRUG

Homeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition

Radium bromatum/Apis mellifica/Belladonna placebo group

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

Group Type: PLACEBO_COMPARATOR

Radium bromatum/Apis mellifica/Belladonna placebo pills

Intervention Type: DRUG

Placebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation

Radium bromatum/Apis mellifica/Belladonna group

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

Group Type: EXPERIMENTAL

Radium bromatum/Apis mellifica/Belladonna pills

Intervention Type: DRUG

Pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation

Interventions

Placebo pills of Radium bromatum

Placebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition

Intervention Type: DRUG

Radium bromatum pills

Homeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition

Intervention Type: DRUG

Radium bromatum/Apis mellifica/Belladonna placebo pills

Placebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation

Intervention Type: DRUG

Radium bromatum/Apis mellifica/Belladonna pills

Pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation

Intervention Type: DRUG

Other Intervention Names

Radium bromatum placebo; Radium bromatum; Radium bromatum/Apis mellifica/Belladonna placebo; Radium bromatum/Apis mellifica/Belladonna

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie Beneton, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2018-002406-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2018-0601

Identifier Type: -

Identifier Source: org_study_id