Spa therapy for treating lymphoedema
Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
NA · Association Francaise pour la Recherche Thermale · NCT03580109
This study is testing if spa therapy combined with education can help people with lymphoedema, especially those who have had breast cancer, feel better compared to those who start treatment later.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Association Francaise pour la Recherche Thermale (other) |
| Drugs / interventions | chemotherapy |
| Locations | 13 sites (Albertville and 12 other locations) |
| Trial ID | NCT03580109 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of spa therapy combined with a therapeutic education program on patients suffering from lymphoedema, particularly those with a history of breast cancer or other malignancies. It is a randomized, controlled, multicenter trial that aims to compare the improvement rates of patients receiving immediate versus late spa treatment over a 6-month period. The study focuses on measuring changes in lymphoedema severity using validated scales. Participants will undergo spa treatment for 18 days and will be followed for 15 months to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with permanent lymphoedema of the upper or lower limb who can commit to the treatment and follow-up schedule.
Not a fit: Patients currently undergoing chemotherapy or radiotherapy, or those with contraindications to spa treatment, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for patients suffering from lymphoedema.
How similar studies have performed: Previous studies have indicated that spa therapy can be beneficial for lymphoedema, suggesting that this approach may yield positive results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old and older * available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months * with permanent lymphoedema of the upper or lower limb (2 ou 3 stade of International Society for Lymphology scale) * voluntary to participate to the study, informed consent form signed after appropriate information * affiliation to the social security system or equivalent Exclusion Criteria: * cancer undergoing chemotherapy and radiotherapy treatment in primary phase * the baseline score of LMS27 or LYMQOL-LEG \> 79 * pain of upper limb linked with a radical plexitis * contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency) * Erysipelas case history in the last 6 months or pachyderma and lymphangiectasia * no previous spa treatment for upper limb lymphoedema during the spa year * risk of intensive treatment in the next 6 months * subject participating to an other clinical study interventional * pregnancy, parturient or breast feeding
Where this trial is running
Albertville and 12 other locations
- Cabinet de médecine vasculaire — Albertville, France (RECRUITING)
- CHU Amiens Picardie — Amiens, France (RECRUITING)
- Thermes Argelès-Gazost — Argelès-Gazost, France (RECRUITING)
- Thermes Barbotan Les Bains — Barbotan-les-Thermes, France (RECRUITING)
- Groupe Hospitalier Mutualiste — Grenoble, France (RECRUITING)
- Thermes La Léchère — La Léchère, France (RECRUITING)
- CH Lourdes — Lourdes, France (RECRUITING)
- Thermes Luz Saint Sauveur — Luz-Saint-Sauveur, France (RECRUITING)
- Centre Léon Berard — Lyon, France (RECRUITING)
- CH Tarbes — Tarbes, France (RECRUITING)
- CHU Toulouse — Toulouse, France (RECRUITING)
- Clinique générale HPDA — Valence, France (RECRUITING)
- Clinique du Tonkin — Villeurbanne, France (RECRUITING)
Study contacts
- Principal investigator: Patrick CARPENTIER, MD — Hospital University Grenoble
- Study coordinator: Alexa COMTE
- Email: alexa.comte@univ-grenoble-alpes.fr
- Phone: 334 76 76 66 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoedema, Breast Cancer, Malignant Disease, Gynaecological Cancer, Lymphoma, Prostate Cancer, Post breast cancer, Spa therapy