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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Placebo pills of Radium bromatum; Drug: Radium bromatum pills; Drug: Radium bromatum/Apis mellifica/Belladonna placebo pills; Drug: Radium bromatum/Apis mellifica/Belladonna pills

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 Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Aurélie Beneton, MD; Phone Number: +33 0477917136; Email: aurelie.beneton@chu-st-etienne.fr
• Study Contact Backup: Name: Mathilde Gras, MsC; Phone Number: +33 0477917136; Email: mathilde.gras@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Radium bromatum placebo group; Placebo group will receive placebo pills of Radium bromatum during radiotherapy	Drug: 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; Other Names: Radium bromatum placebo
Experimental: Radium bromatum group; Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy	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; Other Names: Radium bromatum
Placebo Comparator: 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	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; Other Names: Radium bromatum/Apis mellifica/Belladonna placebo
Experimental: 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	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; Other Names: Radium bromatum/Apis mellifica/Belladonna

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Institut de Cancérologie de la Loire
• Investigators: Principal Investigator: Aurélie Beneton, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Actual): January 5, 2024
• Study Completion (Actual): April 5, 2024

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Homeopathy; Breast cancer; Prevention; Radiotherapy; Radiodermatitis; Radium bromatum; Apis mellifica; Belladonna
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Dermatitis; Radiation Injuries; Breast Neoplasms; Radiodermatitis
• Other Study ID Numbers: 2018-0601; 2018-002406-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No