Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 11/21/2018 |
| Estimated Enrollment Submitted: | 11/21/2018 |
| First Posted: | 11/26/2018 |
| Last Update Submitted: | 07/02/2020 |
| Last Update Posted: | 07/06/2020 |
| Actual Study Start Date: | 07/14/2019 |
| Estimated Primary Completion Date: | 01/30/2021 |
| Estimated Study Completion Date: | 03/30/2021 |
Condition or disease
Intervention/treatment
Drug: Radium bromatum placebo group
Drug: Radium bromatum group
Drug: Radium bromatum/Apis mellifica/Belladonna placebo group
Drug: Radium bromatum/Apis mellifica/Belladonna group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Radium bromatum placebo group Placebo group will receive placebo pills of Radium bromatum during radiotherapy | Drug: Radium bromatum placebo group 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 |
| Experimental: Radium bromatum group Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy | Drug: Radium bromatum group 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 |
| 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 group 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 |
| 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 group 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group [Week 6]
Secondary Outcome Measures
1. Radiodermatitis frequency [Week 6]
2. Radiodermatitis duration [Week 6]
3. Radiodermatitis delays [Week 6]
4. Number of concomitant treatments [Week 6]
5. Pain measure [Week 6]
6. Level of Quality of life [Week 6]
7. Satisfaction measure [Week 6]
