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

Breast Cancer Clinical Trial

— HOMEORAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753776
• Other study ID #: 2018-0601
• Secondary ID: 2018-002406-32
• Status: Completed
• Phase: Phase 3
• Start date: July 15, 2019
• Est. completion date: April 5, 2024

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: April 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiodermatitis

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

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