Clinical trial · Interventional
Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo pills of Radium bromatum | Drug | — | UNRESOLVED |
| Radium bromatum/Apis mellifica/Belladonna pills | Drug | — | UNRESOLVED |
| Radium bromatum/Apis mellifica/Belladonna placebo pills | Drug | — | UNRESOLVED |
| Radium bromatum pills | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- Radium bromatum placebo group
- description
- Placebo group will receive placebo pills of Radium bromatum during radiotherapy
- interventionNames
- Drug: Placebo pills of Radium bromatum
- type
- EXPERIMENTAL
- label
- Radium bromatum group
- description
- Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy
- interventionNames
- Drug: Radium bromatum pills
- type
- PLACEBO_COMPARATOR
- label
- Radium bromatum/Apis mellifica/Belladonna placebo group
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available