Status:

UNKNOWN

Spa Therapy for Upper or Lower Limb Lymphoedema

Lead Sponsor:

Association Francaise pour la Recherche Thermale

Collaborating Sponsors:

Floralis

Conditions:

Lymphoedema

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

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...

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...

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

Key Trial Info

Start Date :

June 20 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT03580109

Start Date

June 20 2019

End Date

December 1 2025

Last Update

March 6 2024

Active Locations (13)

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Page 1 of 4 (13 locations)

1

Cabinet de médecine vasculaire

Albertville, France, 73200

2

CHU Amiens Picardie

Amiens, France, 80054

3

Thermes Argelès-Gazost

Argelès-Gazost, France, 65400

4

Thermes Barbotan Les Bains

Barbotan-les-Thermes, France, 32150

Spa Therapy for Upper or Lower Limb Lymphoedema | DecenTrialz