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Spa Therapy of Upper Limb Lymphoedema (THERMOEDEME)

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ClinicalTrials.gov Identifier: NCT03580109
Recruitment Status : Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
Floralis
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

Brief Summary:

The lymphoedema is a chronic disease caused by an insufficiency of lymphatic system. In France, 100 000 persons are disabled by this disease.

The most classic form is the "swollen arm" which affects the women after surgery and radiotherapy treatments in 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 arm lymphoedema post breast cancer treatments.


Condition or disease Intervention/treatment Phase
Lymphedema Breast Cancer Other: Immediate spa treatment Other: Late spa treatment Not Applicable

Detailed Description:

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 post breast cancer treatments.

According to the protocol submitted to authorities in the absence of evidence data on the subject, the protocol plans to verify the frequency of success (improvement of LMS27 by 7 points) after inclusion and follow-up at 6 months of the first 30 patients in order to reassess the number of subjects required, if the initial hypothesis were too far from reality.

The replacement of the missing values will be done for each dimension, for the patients who answered more than half of the questions, by the average of their answers to the other questions of the dimension.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

2 groups :

  • Immediate spa treatment : the patient realises his spa treatment with education therapeutic soon after the inclusion in study
  • Late spa treatment : the patient realises his spa treatment linked with education therapeutic after 6 months visit
Masking: Single (Investigator)
Masking Description: The investigator doesn't know in wich group his patient is. The spa treatment is organized by the coordinating center.
Primary Purpose: Other
Official Title: Spa Therapy of Upper Limb Lymphoedema : a Randomized and Comparative Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
Active Comparator: Immediate spa treatment
Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
Other: Immediate spa treatment
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)

Sham Comparator: Late spa treatment
Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
Other: Late spa treatment
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)




Primary Outcome Measures :
  1. Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale. [ Time Frame: 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 (better outcome) to 5 (worse outcome). The higher score is low, the better lymphoedema quality of life is.



Secondary Outcome Measures :
  1. Evolution of lymphoedema quality of life assessed by the LMS27 scale. [ Time Frame: 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 (better outcome) to 5 (worse outcome). The higher score is low, the better lymphoedema quality of life is.


  2. Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale. [ Time Frame: 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 (better outcome) to 5 (worse outcome). The higher score is low, the better lymphoedema quality of life is.


  3. Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D [ Time Frame: 6 and 12 months ]

    Improvement of generic quality of life (the Euroquol EQ5D scale) at 6 and 12 months.

    EQ-5D 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 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)


  4. Upper limb evaluation [ Time Frame: 6 and 12 months ]
    Evolution of the volume of the upper extremity evaluated (overall and then by segment) from staged perimeter measurements at 6 and 12 months.

  5. Treatment follow up [ Time Frame: 6 months ]
    Evaluation of the costs induced by lymphoedema at 6 months.

  6. Compliance of spa therapeutic [ Time Frame: After spa therapy ]
    Evaluation of the spa therapeutic compliance : number of health care performed in spa therapy.

  7. Achievement educational aims [ Time Frame: 3 months, 9 months. ]
    Verification of the achievement of educational targets in spa therapy by phone follow up.

  8. Adverse events [ Time Frame: 12 months ]
    Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials.

  9. Functional evaluation [ Time Frame: 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.

  10. Long term evaluation [ Time Frame: 12 months ]
    Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.

  11. Effect size [ Time Frame: 6 and 12 months ]
    Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.

  12. Sub group analysis [ Time Frame: 6 months ]
    Sub group analysis on the primary outcome measure (stratification on primo spa therapy and lymphoedema severity variables)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women, more than 18 years old
  • available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months
  • with a permanent lymphoedema of upper 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580109


Contacts
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Contact: Claire EYCHENNE 334 76 76 50 40 claire.eychenne@univ-grenoble-alpes.fr
Contact: Carole ROLLAND 334 76 76 69 03 carole.rolland@univ-grenoble-alpes.fr

Locations
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France
Cabinet de médecine vasculaire Not yet recruiting
Albertville, France, 73200
Principal Investigator: Michèle VIONNET FUASSET, MD         
Thermes Argelès-Gazost Not yet recruiting
Argelès-Gazost, France, 65400
Thermes Barbotan Les Bains Not yet recruiting
Barbotan-les-Thermes, France, 32150
Thermes La Léchère Not yet recruiting
La Léchère, France, 73260
Thermes Luz Saint Sauveur Not yet recruiting
Luz-Saint-Sauveur, France, 65120
Cabinet de médecine vasculaire Not yet recruiting
Lyon, France, 69002
Principal Investigator: Catherine GROSSETETE, MD         
Clinique du Tonkin Not yet recruiting
Villeurbanne, France, 69100
Principal Investigator: Anne TISSOT, MD         
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
Floralis
Investigators
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Principal Investigator: Patrick CARPENTIER, MD Hospital University Grenoble

Publications:
Lymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54.
Carpentier PH, Fabry R. Crénothérapie des maladies vasculaires. In: Queneau P, editor. Médecine Thermale, faits et preuves. Paris: Masson Ed; 2000. p. 102-15.
Carpentier PH, Satger B, Poensin D, Trens C, Arnold M, Trolliet C, Noilhetas J, Chauvin E, Laurès J Therapeutic education combined with balneotherapy in lymphedema patients. Communication acceptée à l'American Venous Forum (Orlando 25/02/2016, publication en préparation)
Launois R, Alliot F. Quality of Life Scale in Upper Limb Lymphoedema - A validation Study. Lymphology 33, 2000 (Suppl) : 266-74.

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Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT03580109     History of Changes
Other Study ID Numbers: THERMOEDEME
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Association Francaise pour la Recherche Thermale:
Lymphoedema
Post breast cancer
Spa therapy
Education therapeutic

Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases