NCT03580109

Spa Therapy for Upper or Lower Limb Lymphoedema

Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Association Francaise pour la Recherche Thermale · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

THERMOEDEME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial. The aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.

Detailed description

Lymphoedema is a chronic disease related to an insufficiency of the lymphatic system, which most often affects the limbs. Secondary forms are the most common, particularly those following surgical and radiotherapy treatments for cancer, the most classic being the post-therapeutic large arm of breast cancer. The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema. The primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on LMS27 (upper limb lymphoedema) or LYMQOL-LEG (lower limb lymphoedema) (Improvement is defined as 7 points between baseline and 6-month follow-up).

Conditions

• Lymphoedema
• Breast Cancer
• Malignant Disease
• Gynaecological Cancer
• Lymphoma
• Prostate Cancer

Interventions

Type	Name	Description
OTHER	Immediate spa treatment	Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)
OTHER	Late spa treatment	Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)

Timeline

• Start date: 2019-06-20
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2018-07-09
• Last updated: 2024-03-06

Locations

13 sites across 1 country: France