Spa Therapy for Upper or Lower Limb Lymphoedema

Association Francaise pour la Recherche Thermale160 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

160

Conditions

Lymphoedema Breast Cancer Malignant Disease Gynaecological Cancer Lymphoma Prostate Cancer

Interventions

Immediate spa treatmentOTHER

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)

Late spa treatmentOTHER

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)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Cabinet de médecine vasculaire

Albertville, France

RECRUITING

CHU Amiens Picardie

Amiens, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 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.

Central Contacts

Alexa COMTE

CONTACT

334 76 76 66 39 alexa.comte@univ-grenoble-alpes.fr

Carole ROLLAND

CONTACT

334 76 76 69 03 carole.rolland@univ-grenoble-alpes.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Thermes Argelès-Gazost

Argelès-Gazost, France

RECRUITING

Thermes Barbotan Les Bains

Barbotan-les-Thermes, France

RECRUITING

Groupe Hospitalier Mutualiste

Grenoble, France

RECRUITING

Thermes La Léchère

La Léchère, France

RECRUITING

CH Lourdes

Lourdes, France

RECRUITING

Thermes Luz Saint Sauveur

Luz-Saint-Sauveur, France

RECRUITING

Centre Léon Berard

Lyon, France

RECRUITING

CH Tarbes

Tarbes, France

RECRUITING

...and 3 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: 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.

Time frame: 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).

Time frame: 6 and 12 months

Compliance of spa therapy

Evaluation of the spa therapy compliance : number of health care performed in spa therapy.

Time frame: After spa therapy

Achievement educational aims

Verification of the achievement of educational targets in spa therapy by phone follow up.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Effect size

Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.

Time frame: 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)

Time frame: 6 months