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

Institut de Cancérologie de Lorraine142 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

142

Conditions

Breast Carcinoma Fibrosis

Interventions

skin-oriented spa careOTHER

standardized procedure : 72 care sessions over 18 days of treatment +/- Additional care according to the specificity of each spa

PentoxifyllineDRUG

400 mg bid during at least 6 months

Tocopherol acetateDRUG

500 mg bid during at least 6 months

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (21)

CHU de Besançon Hôpital Jean Minjoz

Besançon, France

ONCODOC

Béziers, France

Outcomes

Primary Outcomes

Dermatology Quality of life at 6 months

Self-reported dermatology quality of life using the standardized Dermatology Life Quality Index (DLQI) ; This score assess the functional impact of fibrosis: eg. intensity of pain, itching... (10 items). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Time frame: 6 months after the end of treatment

Secondary Outcomes

Dermatology Quality of life at 12 months

Time frame: 12 months after the end of treatment

Overall quality of life

quality of life questionnaire (EORTC QLQ C30 score)

Time frame: 6 months

Breast-oriented quality of life

EORTC QLQ-BR23 score

Time frame: 6 months

late radiation toxicity

Evaluation of late toxicity performed independently and in blind by another radiation oncologist from the same center, using the CTCAE v4.0 scale modules: Skin and subcutaneous tissue disorders / Musculoskeletal skeletal / Reproductive organs and breast

Time frame: 6 months

Skin thickness

The skin thickness will be assessed in blind by an independently radiologist using a standardized Ultrasound scan procedure (Yoshida EJ, et al; Int J Radiat Oncol Biol Phys. 2012) Skin thickness is measured as the distance between the entry ultrasound echo signal to the border between the dermis and hypodermis . Measurements are acquired from ten locations: five on the treated (irradiated) breast (12:00, 3:00, 6:00, 9:00, and tumor bed), and five corresponding locations on the untreated (contralateral) breast - serving as controls to account for patient baseline variation

Central Contacts

MERLIN Jean Louis

CONTACT

0033383598307 jl.merlin@nancy.unicancer.fr

FERNANDES Laurinda

CONTACT

0033383598487 l.fernandes@nancy.unicancer.fr

Data from ClinicalTrials.gov

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