Spa Therapy for Upper or Lower Limb Lymphoedema
- Conditions
- LymphomaProstate CancerLymphoedemaBreast CancerGynaecological CancerMalignant Disease
- Interventions
- Other: Late spa treatmentOther: Immediate spa treatment
- Registration Number
- NCT03580109
- Lead Sponsor
- Association Francaise pour la Recherche Thermale
- Brief 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 160
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late spa treatment Late spa treatment Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization Immediate spa treatment Immediate spa treatment Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
- Primary Outcome Measures
Name Time Method Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema). 6 months 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.Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LYMQOL-LEG scale (for lower limb lymphoedema). 6 months 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.
- Secondary Outcome Measures
Name Time Method Achievement educational aims 3 months, 9 months. Verification of the achievement of educational targets in spa therapy by phone follow up.
Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema). 6 and 12 months 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.Upper or lower limb evaluation 6 and 12 months 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.
Consumption of care between the 2 groups (immediate treatment/delayed treatment) 6 and 12 months Evaluation of the costs incurred by lymphoedema (hospitalisations, medical and paramedical acts, treatments).
Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy. 6 and 12 months 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.Compliance of spa therapy After spa therapy Evaluation of the spa therapy compliance : number of health care performed in spa therapy.
Long term evaluation 12 months Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.
Sub group analysis 6 months Sub group analysis on the primary outcome measure (stratification on primo spa therapy, lymphoedema severity and lymphoedema localization)
Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LYMQOL-LEG scale (for lower limb lymphoedema) 6 and 12 months 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.Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L 6 and 12 months 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)Adverse events 12 months Evaluation of all adverse events related to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials.
Functional evaluation 12 months 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.
Effect size 6 and 12 months Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.
Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy. 6 and 12 months 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.
Trial Locations
- Locations (13)
CHU Amiens Picardie
🇫🇷Amiens, France
Cabinet de médecine vasculaire
🇫🇷Albertville, France
Thermes Argelès-Gazost
🇫🇷Argelès-Gazost, France
Thermes Barbotan Les Bains
🇫🇷Barbotan-les-Thermes, France
Thermes La Léchère
🇫🇷La Léchère, France
Groupe Hospitalier Mutualiste
🇫🇷Grenoble, France
CH Lourdes
🇫🇷Lourdes, France
Thermes Luz Saint Sauveur
🇫🇷Luz-Saint-Sauveur, France
Centre Léon Berard
🇫🇷Lyon, France
CHU Toulouse
🇫🇷Toulouse, France
CH Tarbes
🇫🇷Tarbes, France
Clinique générale HPDA
🇫🇷Valence, France
Clinique du Tonkin
🇫🇷Villeurbanne, France