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

NCT03753776 | Completed Phase 3

• 2 other identifiers: 2018-06012018-002406-32
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Homeopathy; Radium bromatum; Apis mellifica; Belladonna; Radiodermatitis; Radiotherapy; Prevention; Treatment; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group

  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

  Week 6

Secondary Outcomes (7)

• Radiodermatitis frequency

  Week 6

• Radiodermatitis duration

  Week 6

• Radiodermatitis delays

  Week 6

• Number of concomitant treatments

  Week 6

• Pain measure

  Week 6

Study Arms (4)

Radium bromatum placebo group

PLACEBO COMPARATOR

Placebo group will receive placebo pills of Radium bromatum during radiotherapy

Drug: Placebo pills of Radium bromatum

Radium bromatum group

EXPERIMENTAL

Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy

Drug: Radium bromatum pills

Radium bromatum/Apis mellifica/Belladonna placebo group

PLACEBO COMPARATOR

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

Drug: Radium bromatum/Apis mellifica/Belladonna placebo pills

Radium bromatum/Apis mellifica/Belladonna group

EXPERIMENTAL

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

Drug: Radium bromatum/Apis mellifica/Belladonna pills

Interventions

Placebo pills of Radium bromatum 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

Also known as: Radium bromatum placebo

Radium bromatum placebo group

Radium bromatum pills 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

Also known as: Radium bromatum

Radium bromatum group

Radium bromatum/Apis mellifica/Belladonna placebo pills 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

Also known as: Radium bromatum/Apis mellifica/Belladonna placebo

Radium bromatum/Apis mellifica/Belladonna placebo group

Radium bromatum/Apis mellifica/Belladonna pills 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

Also known as: Radium bromatum/Apis mellifica/Belladonna

Radium bromatum/Apis mellifica/Belladonna group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Institut de Cancérologie de la Loire: collaborator

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Aurélie Beneton, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A first randomization will establish two groups : placebo versus homeopathy (Radium bromatum), and if patients develop a radiodermatitis of grade 2 or higher, a second randomization will take place, with two groups : placebo versus homeopathy (Radium bromatum, Apis mellifica, and Belladonna)

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 27, 2018
• Study Start: July 15, 2019
• Primary Completion: January 5, 2024
• Study Completion: April 5, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)