Clinical Benefit of Spa Care on Severe Radiation-induced Fibrosis After Postoperative Radiotherapy for Breast Cancer (FIBROTHERME)

Institut de Cancérologie de Lorraine

Status and phase: Unknown; Phase 3

Conditions: Fibrosis; Breast Carcinoma

Treatments: Drug: Tocopherol acetate; Other: skin-oriented spa care; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT02898376

2016-003518-28

Details and patient eligibility

About

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.

Full 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.

Enrollment: 142 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

combination tocopherol/pentoxifylline + spa care

Experimental group

Description:

pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months AND skin-oriented spa care (18 days)

Treatment:

Drug: Pentoxifylline

Drug: Tocopherol acetate

Other: skin-oriented spa care

combination tocopherol/pentoxifylline

Active Comparator group

Description:

pentoxifylline (400 mg bid) + tocopherol (500 mg x bid) during at least 6 months

Treatment:

Drug: Pentoxifylline

Drug: Tocopherol acetate