Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Postoperative Radiotherapy for Breast Cancer

Launched by ASSOCIATION FRANCAISE POUR LA RECHERCHE THERMALE · May 15, 2023

Keywords

ClinConnect Summary

**Summary of the Clinical Trial: FIBROTHERME**

The FIBROTHERME trial is studying whether spa therapy can help women who have experienced skin and soft tissue problems (known as fibrosis) after undergoing radiation treatment for breast cancer. Specifically, the trial aims to see if this type of therapy can improve patients' quality of life six months after treatment. The study is currently looking for women aged 18 and older who have had breast cancer and significant skin issues due to past radiation therapy. To join the trial, participants need to have completed their radiation treatment at least six months ago and show that their skin problems are having a moderate to severe impact on their daily lives.

If eligible and enrolled, participants will receive spa therapy and will be monitored to see how it affects their skin and overall well-being. Throughout the trial, they will be supported by healthcare professionals and will have the opportunity to share their experiences. It's important to note that this trial is not for women with certain complications, such as ongoing cancer treatment or specific skin conditions, and those who are pregnant or breastfeeding are also excluded. The goal of the study is to find better ways to help women feel more comfortable and improve their quality of life after breast cancer treatment.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female
• • Age ≥ 18 years
• • In situ or invasive breast cancer
• • DLQI ≥ 6 (at least moderate effect on patient's life)
• • General status WHO 0-1
• • Post-operative radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)
• • Unilateral breast radiotherapy
• • Skin or soft tissue toxicity (- modules: Skin and subcutaneous tissue disorders / Musculoskeletal disorders / Reproductive organs and breast disorders) CTCAE v4.0 grade ≥ 2
• • No inflammatory or infectious flare at inclusion
• • Female of childbearing potential: negative urine pregnancy test at inclusion
• • Patient informed and signed consent
• • Affiliation to a social security systeme or equivalent
• Exclusion Criteria:
• • Progressive phase of cancer
• • Metastatic disease
• • Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and/or adjuvant herceptin)
• • Bilateral breast/parietal radiotherapy
• • Breast prosthesis wearer
• • Obvious skin ulceration in the treated breast
• • Contraindication to spa treatment (acute inflammatory disease, active infections, heart failure with NYHA stage \> 1, chronic respiratory failure, labile hypertension, bullous disease)
• • Chronic progressive dermatological disease
• • Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding
• • Persons deprived of liberty or under guardianship