Clinical trial · Interventional
Spa Therapy for Upper or Lower Limb Lymphoedema
Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
NCT03580109CI-TRIAL-00074775THERMOEDEMEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Gynaecological Cancer | — | UNRESOLVED | — |
| Lymphoedema | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Malignant Disease | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immediate spa treatment | Other | — | UNRESOLVED |
| Late spa treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Immediate spa treatment
- description
- Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
- interventionNames
- Other: Immediate spa treatment
- type
- SHAM_COMPARATOR
- label
- Late spa treatment
- description
- Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
- interventionNames
- Other: Late spa treatment
Primary outcomes (2)
- measure
- Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDRockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. PMID 18519968
- BACKGROUNDInternational Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology. 2003 Jun;36(2):84-91. PMID 12926833
- BACKGROUNDCarpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15. PMID 24135621
- BACKGROUNDPusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5. PMID 23212603
- BACKGROUNDNorman GR, Sloan JA, Wyrwich KW. The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Rev Pharmacoecon Outcomes Res. 2004 Oct;4(5):581-5. doi: 10.1586/14737167.4.5.581. PMID 19807551
- BACKGROUNDNorman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C. PMID 12719681
- BACKGROUNDDevoogdt N, Lemkens H, Geraerts I, Van Nuland I, Flour M, Coremans T, Christiaens MR, Van Kampen M. A new device to measure upper limb circumferences: validity and reliability. Int Angiol. 2010 Oct;29(5):401-7.