Status:
COMPLETED
Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Institut de Cancérologie de la Loire
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 trea...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2024
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT03753776
Start Date
July 15 2019
End Date
April 5 2024
Last Update
April 9 2025
Active Locations (1)
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1
CHU de Saint-Etienne
Saint-Etienne, France, 42055