Spa Therapy for Upper or Lower Limb Lymphoedema (THERMOEDEME)

Association Francaise pour la Recherche Thermale

Status: Enrolling

Conditions: Malignant Disease; Breast Cancer; Lymphoedema; Lymphoma; Gynaecological Cancer; Prostate Cancer

Treatments: Other: Immediate spa treatment; Other: Late spa treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03580109

THERMOEDEME

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Immediate spa treatment

Active Comparator group

Description:

Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts

Treatment:

Other: Immediate spa treatment

Late spa treatment

Sham Comparator group

Description:

Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization

Treatment:

Other: Late spa treatment