Clinical trial NCT03580109: Spa Therapy for Upper or Lower Limb Lymphoedema
Official title: Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoedema
Breast Cancer
Malignant Disease
Gynaecological Cancer
Lymphoma
Prostate Cancer
Keywords: Lymphoedema
Post breast cancer
Spa therapy
Education therapeutic
Malignant Disease
Post gynaecological cancer
Post Lymphoma
Post prostate cancer
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: Floralis
First posted: 2018-07-09
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

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).

Eligibility 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

Primary outcomes:
measure: Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema).
timeFrame: 6 months
measure: Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LYMQOL-LEG scale (for lower limb lymphoedema).
timeFrame: 6 months
Secondary outcomes:
measure: Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy.
timeFrame: 6 and 12 months
measure: Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy.
timeFrame: 6 and 12 months
measure: Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema).
timeFrame: 6 and 12 months
measure: Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LYMQOL-LEG scale (for lower limb lymphoedema)
timeFrame: 6 and 12 months
measure: Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L
timeFrame: 6 and 12 months
measure: Upper or lower limb evaluation
timeFrame: 6 and 12 months
measure: Consumption of care between the 2 groups (immediate treatment/delayed treatment)
timeFrame: 6 and 12 months
measure: Compliance of spa therapy
timeFrame: After spa therapy
measure: Achievement educational aims
timeFrame: 3 months, 9 months.
measure: Adverse events
timeFrame: 12 months
measure: Functional evaluation
timeFrame: 12 months
measure: Long term evaluation
timeFrame: 12 months
measure: Effect size
timeFrame: 6 and 12 months
measure: Sub group analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Albertville
country: France
facility: Cabinet de médecine vasculaire
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Argelès-Gazost
country: France
facility: Thermes Argelès-Gazost
city: Barbotan-les-Thermes
country: France
facility: Thermes Barbotan Les Bains
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste
city: La Léchère
country: France
facility: Thermes La Léchère
city: Lourdes
country: France
facility: CH Lourdes
city: Luz-Saint-Sauveur
country: France
facility: Thermes Luz Saint Sauveur
city: Lyon
country: France
facility: Centre Léon Berard
city: Tarbes
country: France
facility: CH Tarbes
city: Toulouse
country: France
facility: CHU Toulouse
city: Valence
country: France
facility: Clinique générale HPDA
city: Villeurbanne
country: France
facility: Clinique du Tonkin
Study officials:
affiliation: Hospital University Grenoble
name: Patrick CARPENTIER, MD
role: PRINCIPAL_INVESTIGATOR
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