Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT05874492
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05874492
Study Brief:
Protocol Section:
NCT05874492