Breast Cancer
Conditions
Keywords
Homeopathy, Radium bromatum, Apis mellifica, Belladonna, Radiodermatitis, Radiotherapy, Prevention, Treatment, Breast cancer
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.
Interventions
DRUGPlacebo 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
DRUGRadium 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
DRUGRadium 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
DRUGRadium 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
Sponsors
Institut de Cancérologie de la Loire
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)
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)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage diminution of grade 2 or higher radiodermatitis in Radium bromatum group | Week 6 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiodermatitis duration | Week 6 | Radiodermatitis duration will be reported in days. |
| Radiodermatitis delays | Week 6 | Radiodermatitis delays will be reported in days. |
| Number of concomitant treatments | Week 6 | Number of concomitant treatments will be reported. |
| Radiodermatitis frequency | Week 6 | Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported. |
| Level of Quality of life | Week 6 | Level of Quality of life will be measured between 0 to 100 with the EQ-5D questionnaire (european quality of life number 5) |
| Satisfaction measure | Week 6 | Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction) |
| Pain measure | Week 6 | Measure of pain will be reported, calculated with a oral scale between 0 and 10. |
Countries
France
Outcome results
None listed