Clinical trial · Interventional
Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer
Evaluation of the Clinical Benefit of a Spa Care on the Evolution of Late Fibrosis After Postoperative Radiotherapy for Breast Cancer in Remission
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pentoxifylline | Drug | — | UNRESOLVED |
| skin-oriented spa care | Other | — | UNRESOLVED |
| Tocopherol acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- combination tocopherol/pentoxifylline + spa care
- description
- pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)
- interventionNames
- Other: skin-oriented spa care
- Drug: Pentoxifylline
- Drug: Tocopherol acetate
- type
- ACTIVE_COMPARATOR
- label
- combination tocopherol/pentoxifylline
- description
- pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months
- interventionNames
- Drug: Pentoxifylline
- Drug: Tocopherol acetate
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * women * age ≥ 18 and \<80 years old * invasive or in situ breast carcinoma * non-metastatic disease. * postoperative radiotherapy completed since at least 6 months * unilateral breast radiotherapy * grade \> 2 dermal and/or soft tissue toxicity (CTCAE v4.0) * no inflammatory ou infectious flare on the breast at the time of inclusion * ability to provide an informed written consent form * affiliation to a social security system Exclusion Criteria: * age \<18 or ≥ 80 years old * evolutive cancer * Metastatic Disease * Patient undergoing specific treatment for breast cancer (except adjuvant endocrine therapy and / or adjuvant Herceptin) at the time of inclusion * bilateral Breast/chest wall Radiotherapy * breast prosthesis bearer * Body Mass Index \> 40 or \<18.5 * chronic skin ulceration within the treated breast at the time of inclusion * contraindications to spa care : * inflammatory disease in flare at the time of inclusion * active infections * heart failure (NYHA class\> 1) * chronic respiratory failure * labile blood pressure * bullous dermatitis * evolutive chronic skin disease * hypersensitivity to pentoxifylline or any of the excipients * acute myocardial infarction * ongoing hemorrhage or major bleeding risk * use of oral anticoagulants * pregnant or likely to be in 6 months or breastfeeding * patients deprived of liberty or under supervision
References
Publications (0)
Data not yet available