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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Recruiting

CT.gov ID

NCT03753776

Collaborator

Institut de Cancérologie de la Loire (Other)

232

Enrollment

Location

Arms

44.5

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	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	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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)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)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Radiodermatitis frequency [Week 6]
Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported.
Radiodermatitis duration [Week 6]
Radiodermatitis duration will be reported in days.
Radiodermatitis delays [Week 6]
Radiodermatitis delays will be reported in days.
Number of concomitant treatments [Week 6]
Number of concomitant treatments will be reported.
Pain measure [Week 6]
Measure of pain will be reported, calculated with a oral scale between 0 and 10.
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)
Satisfaction measure [Week 6]
Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.