Indication of curative radiotherapy after conservative breast cancer surgery. Accepted scheme of radiotherapy: 50 Gy (main) + 16 Gy on the tumoral bed (supplement of dose). MedDRA version: 20.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant
Conditions
Interventions
Trade Name: Radium bromatum 15 CH
Product Name: Radium bromatum 15 CH
Pharmaceutical Form: Granules
Pharmaceutical form of the placebo: Granules
Route of administration of the placebo: Oral use
Trade
Sponsors
Institut de Cancérologie Lucien Neuwirth
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Major patient; - Indication of curative radiotherapy after conservative breast cancer surgery. 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 received informed information about the study and who co-signed, with the investigator, a consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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 (articles L.1121-6, L.1121-7, L.1211-8, L.1211-9); - 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 |
|---|---|
| Main Objective: The main objective of this study is to compare the incidence of grade 2 and higher radiodermites between patients receiving homeopathic granules (Radium bromatum) versus placebo granules.;Secondary Objective: - Occurrence of radiodermatitis of all grades; - Durations of radiodermites of all grades; - Time of appearance of radiodermites of all grades; - Use of allopathic remedies; - Pain (evaluated on a 10cm visual analogue scale); - Quality of life ; - Sequelae following radiodermatitis; - Adherence to treatment; - Radiotherapy protocol actually received; - Patient satisfaction about homeopathy.;Primary end point(s): Decrease in the occurrence of radiodermites of grade 2 or higher by at least 10%, graded according to the RTOG (Radiation Therapy Oncology Group) scale.;Timepoint(s) of evaluation of this end point: 6 weeks after radiotherapy (+/-7 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Frequency of radiodermites of all grades in both groups, with radiodermites graded according to the Radiation Therapy Oncology Group (RTOG) scale; - Durations of radiodermites of all grades; - Time of appearance of radiodermites of all grades; - Treatments administered (nature, dosage, duration); - Pain of the patients; - Patient quality of life measured via EQ-5D; - Sequelae due to radiodermatitis: nature of the sequelae reported by the radiotherapist at 6 weeks post-radiotherapy; - Compliance with treatment (assessed via the interview between the patient and the doctor who follows him); - Radiotherapy protocol actually received: total dose received, number of days of radiation interruption; - Patient satisfaction with homeopathy / placebo graded on a scale of 0 to 3; - Relationship between radiodermites and extrinsic factors: dose Dmax; the nature of ionizing particles (photons, electrons); the topography of the irradiated area; the irradiation technique; - Relationship between radiodermites and the following intrinsic factors: phenotypic and genotypic characteristics of the patients: Age, diabetes, immunodepression, undernutrition, tobacco, obesity, skin phototype, initial integrity of the skin; cup size; menopausal status; concomitant treatment with herceptin; toxicological status (tobacco, alcohol, drugs).;Timepoint(s) of evaluation of this end point: 6 weeks after radiotherapy (+/-7 days). | — |
Countries
France
Contacts
Public ContactMathilde Gras
Institut de Cancérologie Lucien Neuwirth
Outcome results
None listed