E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
Indication de radiothérapie en intention curative pour un cancer du sein ayant bénéficié d’un traitement conservateur. Schéma de radiothérapie accepté : 50 Gy (principal) + 16 Gy sur le lit tumoral (complément de dose).
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E.1.1.1 | Medical condition in easily understood language |
Indication of radiotherapy after a conservative breast cancer surgery. |
Indication de radiothérapie en intention curative pour un cancer du sein ayant bénéficié d’un traitement conservateur. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
L’objectif principal de cette étude est de comparer l’incidence de radiodermites de grade 2 et plus entre les patientes bénéficiant de granules homéopathiques à base de Radium bromatum versus granules placebo. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
- Survenue de radiodermites de tous grades ; - Durées des radiodermites de tous grades ; - Délais d’apparition des radiodermites de tous grades ; - Recours à des traitements curatifs allopathiques ; - Douleurs (évaluées sur une échelle visuelle analogique de 10cm) ; - Qualité de vie ; - Séquelles des suites des radiodermites ; - Observance au traitement ; - Protocole de radiothérapie effectivement reçu ; - Satisfaction des patientes à propos de l’homéopathie. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
- Patiente majeure ; - Indication de radiothérapie en intention curative pour un cancer du sein ayant bénéficié d’un traitement conservateur. Schéma de radiothérapie accepté : 50 Gy (principal) + 16 Gy sur le lit tumoral (complément de dose) ; - Patiente affiliée ou ayant droit à un régime de sécurité sociale ; - Patiente ayant reçu une information éclairée sur l’étude et ayant co-signé, avec l’investigateur, un consentement de participation à l’étude.
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E.4 | Principal 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. |
- Femme enceinte ou allaitante ; - Incapacité légale ou capacité légale limitée. Conditions médicales ou psychologiques ne permettant pas au sujet de comprendre l’étude et signer le consentement (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9) ; - Patiente suivie par un homéopathe libéral ; - Patiente présentant un cancer du sein bilatéral ; - Patiente présentant un cancer du sein in situ ; - Patiente présentant des troubles cognitifs connus ; - Patiente présentant une allergie et/ou une intolérance et/ou une malabsorption connue(s) au fructose, glucose, galactose ; - Patiente présentant un déficit connu en sucrase/isomaltase/lactase. |
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E.5 End points |
E.5.1 | 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. |
Diminution de la survenue de radiodermites de grade supérieur ou égal à 2 d’au moins 10%, gradées selon l’échelle de la RTOG (Radiation Therapy Oncology Group). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 weeks after radiotherapy (+/-7 days). |
6 semaines de la fin de la radiothérapie (à +/- 7 jours). |
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E.5.2 | 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). |
- Fréquence des radiodermites de tous grades dans les deux groupes, les radiodermites étant gradées selon l’échelle de la RTOG (Radiation Therapy Oncology Group) ; - Durées des radiodermites de tous grades ; - Délais d’apparition des radiodermites de tous grades ; - Traitements administrés (nature, posologie, durée) ; - Douleur des patientes ; - Qualité de vie des patientes mesurée via l’EQ-5D ; - Séquelles dues à la radiodermite : nature des séquelles reportées par le radiothérapeute à 6 semaines post-radiothérapie ; - Observance au traitement (évaluée via l’entretien entre le patient et le médecin qui le suit) ; - Protocole de radiothérapie effectivement reçu : dose totale reçue, nombre de jours d’interruption des rayons ; - Satisfaction des patientes à propos de l’homéopathie/du placebo gradée sur une échelle de 0 à 3 ; - Relation entre les radiodermites et les facteurs extrinsèques suivants : la dose Dmax ; la nature des particules ionisantes (photons, électrons) ; la topographie de la zone irradiée ; la technique d’irradiation ; - Relation entre les radiodermites et les facteurs intrinsèques suivants : caractéristiques phénotypiques et génotypiques des patientes : Age, diabète, immunodépression, dénutrition, tabac, obésité, phototype cutané, intégrité initiale du revêtement cutané ; taille du bonnet ; statut ménopausique ; traitement concomitant à l’herceptine ; statut toxicologique (tabac, alcool, drogues).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 weeks after radiotherapy (+/-7 days). |
6 semaines de la fin de la radiothérapie (à +/- 7 jours). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last Visit of Last Subject (LVLS). |
Dernière visite du dernier patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |