NCT02898376

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The combination of PTX and vit E appears as the standard treatment of radiation induced fibrosis. Synergism between PTX and Vit E is likely, as treatment with each drug alone is ineffective. This combination was also positively evaluated in the treatment of osteoradionecrosis, radiation-induced pelvic neuropathies, pneumoniae as well as bowel pathologies. Spa cares are part of the standard treatment of burn scars. Two spa treatments per year enable the mitigation or disappearance (after several treatments) of pruritus, dysesthesia, local inflammation, hypertrophy and sclerosis. They promote the healing of chronic superficial erosions. The spa treatment combines baths, sprays and especially filiform showers with thermal water jets under high pressure for a few minutes.

Conditions

• Breast Carcinoma
• Fibrosis

Interventions

Type	Name	Description
OTHER	skin-oriented spa care	standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa
DRUG	Pentoxifylline	400 mg bid during at least 6 months
DRUG	Tocopherol acetate	500 mg bid during at least 6 months

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-07-01
• Completion: 2021-12-01
• First posted: 2016-09-13
• Last updated: 2018-08-08

Locations

21 sites across 1 country: France