Spa Therapy for Upper or Lower Limb Lymphoedema

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Lymphoedema, Breast Cancer, Malignant Disease, Gynaecological Cancer, Lymphoma, Prostate Cancer

Intervention / Treatment
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* Other: Immediate spa treatment
* Other: Late spa treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2 groups: Immediate spa therapy: the patient carries out the spa therapy with education therapeutic soon after the enrolment in the study Late spa therapy: the patient carries out the spa therapy with education therapeutic after the 6-month follow up
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate spa treatment<br>Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts | Other: Immediate spa treatment<br>* 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)<br>|
| Sham Comparator: Late spa treatment<br>Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization | Other: Late spa treatment<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema). | Rate of patients with an improvement of 7 points minimum of the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 months. The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is. | 6 months | 
| Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LYMQOL-LEG scale (for lower limb lymphoedema). | Rate of patients with an improvement of 7 points minimum of the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 months. The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot. In order to to standardize with the LMS27 scale (for upper limb lymphoedema), the quotations are reversed: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy. | Evolution of the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 and 12 months. The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is. | 6 and 12 months | 
| Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy. | Evolution of the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 and 12 months. The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot. In order to to standardize with the LMS27 scale (for upper limb lymphoedema), the quotations are reversed: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is. | 6 and 12 months | 
| Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema). | Evolution of 5 items the most embarrassing chosen by the patients in the LMS27 scale (specific quality of life scale in upper limb lymphoedema) at 6 and 12 months. The LMS27 scale is composed of 27 questions with 5 answers possible : never, rarely, sometimes, often, always. The answer's score is respectively 1 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is. | 6 and 12 months | 
| Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LYMQOL-LEG scale (for lower limb lymphoedema) | Evolution of 5 items the most embarrassing chosen by the patients in the LYMQOL-LEG scale (specific quality of life scale in lower limb lymphoedema) at 6 and 12 months. The LYMQOL-LEG scale is composed of 26 questions with 4 answers possible: not at all, a little, quite a bit, a lot. In order to to standardize with the LMS27 scale (for upper limb lymphoedema), we decide to reverse the quotations: the answer's score is respectively 1 (worse outcome) to 4 (better outcome). The higher the score is, the better the lymphoedema quality of life is. | 6 and 12 months | 
| Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L | Improvement of generic quality of life (the Euroquol EQ5D-3L scale) at 6 and 12 months. EQ5D-3L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of lige that can be used in a wide range of health conditions and treatments. The EQ5D-3L has 6 items intended to measure general health. The top 5 rate mobility, independence, daily activities, pain / discomfort, and anxiety / depression, and are rated according to 3 values from No problem to Problem or Incapacity. This results in an index score. The last item deals with perceived health on the day the questionnaire is filled in and uses a visual analogue scale from 0 (wors) to 100 (best health possible) (Visual Analog Scale Score) | 6 and 12 months | 
| Upper or lower limb evaluation | Evolution of the volume of the upper or lower extremity evaluated (overall and then by segment) from staged perimeter measurements at 6 and 12 months. | 6 and 12 months | 
| Consumption of care between the 2 groups (immediate treatment/delayed treatment) | Evaluation of the costs incurred by lymphoedema (hospitalisations, medical and paramedical acts, treatments). | 6 and 12 months | 
| Compliance of spa therapy | Evaluation of the spa therapy compliance : number of health care performed in spa therapy. | After spa therapy | 
| Achievement educational aims | Verification of the achievement of educational targets in spa therapy by phone follow up. | 3 months, 9 months. | 
| Adverse events | Evaluation of all adverse events related to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials. | 12 months | 
| Functional evaluation | Monthly measurements of functional discomfort from inclusion to 12 months; The functional discomfort is measured monthly by a visual scale : not discomfort to maximal discomfort. | 12 months | 
| Long term evaluation | Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes. | 12 months | 
| Effect size | Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes. | 6 and 12 months | 
| Sub group analysis | Sub group analysis on the primary outcome measure (stratification on primo spa therapy, lymphoedema severity and lymphoedema localization) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoedema, Post breast cancer, Spa therapy, Education therapeutic, Malignant Disease, Post gynaecological cancer, Post Lymphoma, Post prostate cancer