Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002406-32 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institut de Cancérologie de la Loire | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium bromatum placebo group | Placebo Comparator | Placebo group will receive placebo pills of Radium bromatum during radiotherapy |
|
| Radium bromatum group | Experimental | Radium bromatum group will receive homeopathic Radium bromatum pills during radiotherapy |
|
| Radium bromatum/Apis mellifica/Belladonna placebo group | Placebo Comparator | Placebo group will receive Radium bromatum/Apis mellifica/Belladonna placebo pills to treat grade 2 or higher radiodermatitis |
|
| Radium bromatum/Apis mellifica/Belladonna group | Experimental | Radium bromatum/Apis mellifica/Belladonna group will receive homeopathic Radium bromatum/Apis mellifica/Belladonna pills to treat grade 2 or higher radiodermatitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo pills of Radium bromatum | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Radiodermatitis frequency | Number of Radiodermatitis according to the RTOG (Radiation Therapy Oncology Group) scale will be reported. | Week 6 |
| Radiodermatitis duration | Radiodermatitis duration will be reported in days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aurélie Beneton, MD | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Neither patients receiving pills nor doctors evaluating radiodermatitis know the nature of treatment (placebo or homeopathy)
|
| Radium bromatum pills | Drug | 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 | Drug | 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 | Drug | 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 |
|
|
| Week 6 |
| Radiodermatitis delays | Radiodermatitis delays will be reported in days. | Week 6 |
| Number of concomitant treatments | Number of concomitant treatments will be reported. | Week 6 |
| Pain measure | Measure of pain will be reported, calculated with a oral scale between 0 and 10. | Week 6 |
| 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 |
| Satisfaction measure | Satisfaction will be measured with a oral scale between 0 (no satisfaction) and 3 (full satisfaction) | Week 6 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D003872 | Dermatitis |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided