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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Radium bromatum placebo group<br>Placebo group will receive placebo pills of Radium bromatum during radiotherapy | Drug: Placebo pills of Radium bromatum<br>* 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<br>* Other names: Radium bromatum placebo;|
| Experimental: Radium bromatum group<br>Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy | Drug: Radium bromatum pills<br>* 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<br>* Other names: Radium bromatum;|
| Placebo Comparator: Radium bromatum/Apis mellifica/Belladonna placebo group<br>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<br>* 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<br>* Other names: Radium bromatum/Apis mellifica/Belladonna placebo;|
| Experimental: Radium bromatum/Apis mellifica/Belladonna group<br>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<br>* 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<br>* Other names: Radium bromatum/Apis mellifica/Belladonna;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homeopathy, Radium bromatum, Apis mellifica, Belladonna, Radiodermatitis, Radiotherapy, Prevention, Treatment, Breast cancer