Clinical trial NCT03753776: Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
Official title: Phase III Trial Evaluating Radium Bromatum Homeopathic Treatment Efficacy on Radiodermatitis Prevention and Treatment for Breast Cancer Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Homeopathy
Radium bromatum
Apis mellifica
Belladonna
Radiodermatitis
Radiotherapy
Prevention
Treatment
Breast cancer
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Institut de Cancérologie de la Loire
First posted: 2018-11-27
Enrollment: 232
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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 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: 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.

Eligibility 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.

Primary outcomes:
measure: Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group
timeFrame: Week 6
Secondary outcomes:
measure: Radiodermatitis frequency
timeFrame: Week 6
measure: Radiodermatitis duration
timeFrame: Week 6
measure: Radiodermatitis delays
timeFrame: Week 6
measure: Number of concomitant treatments
timeFrame: Week 6
measure: Pain measure
timeFrame: Week 6
measure: Level of Quality of life
timeFrame: Week 6
measure: Satisfaction measure
timeFrame: Week 6
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Aurélie Beneton, MD
role: PRINCIPAL_INVESTIGATOR
References: