drugset / Trial / NCT02898376
Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer
Phase 3
Unknown
142 enrolled
Institut de Cancérologie de Lorraine
Association Francaise pour la Recherche Thermale · collab
RandomizedParallel-groupOpen-labelSupportive care
Summary
This study evaluates the dermatological life quality six months after spa cares in patients with severe late toxicity involving the skin and / or soft tissues after postoperative radiotherapy for breast cancer. Half of the patients will be treated with a combination of pentoxifylline (PTX) and alpha-tocopherol (Vit E) when Half of the patients will receive skin-oriented spa cares in addition.
Timeline
- Start
- 2018-12
- Primary completion
- 2020-07
- Completion
- 2021-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Pentoxifylline | Small molecule | 400 mg | — |
| Background | Tocopherol acetate | Small molecule | 500 mg | — |