Spa Therapy for Upper Limb Lymphoedema (THERMOEDEME)
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| ClinicalTrials.gov Identifier: NCT03580109 |
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Recruitment Status :
Recruiting
First Posted : July 9, 2018
Last Update Posted : January 6, 2021
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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 |
|---|---|---|
| Lymphoedema Breast Cancer | Other: Immediate spa treatment Other: Late spa treatment | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 2 groups :
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| 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 for Upper Limb Lymphoedema : a Randomized and Comparative Study |
| Actual Study Start Date : | June 20, 2019 |
| Estimated Primary Completion Date : | June 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Immediate spa treatment
Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
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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) |
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Sham Comparator: Late spa treatment
Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
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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) |
- 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.
- 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.
- 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.
- 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)
- 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.
- Treatment follow up [ Time Frame: 6 months ]Evaluation of the costs induced by lymphoedema at 6 months.
- Compliance of spa therapeutic [ Time Frame: After spa therapy ]Evaluation of the spa therapeutic compliance : number of health care performed in spa therapy.
- Achievement educational aims [ Time Frame: 3 months, 9 months. ]Verification of the achievement of educational targets in spa therapy by phone follow up.
- 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.
- 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.
- 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.
- 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.
- Sub group analysis [ Time Frame: 6 months ]Sub group analysis on the primary outcome measure (stratification on primo spa therapy and lymphoedema severity variables)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
- the baseline score of LMS27 > 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
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
| Contact: Alexa COMTE | 334 76 76 66 39 | alexa.comte@univ-grenoble-alpes.fr | |
| Contact: Carole ROLLAND | 334 76 76 69 03 | carole.rolland@univ-grenoble-alpes.fr |
| France | |
| Cabinet de médecine vasculaire | Recruiting |
| Albertville, France, 73200 | |
| Principal Investigator: Michèle VIONNET FUASSET, MD | |
| CHU Amiens Picardie | Recruiting |
| Amiens, France, 80054 | |
| Principal Investigator: Simon SOUDET | |
| Thermes Argelès-Gazost | Recruiting |
| Argelès-Gazost, France, 65400 | |
| Thermes Barbotan Les Bains | Recruiting |
| Barbotan-les-Thermes, France, 32150 | |
| Groupe Hospitalier Mutualiste | Recruiting |
| Grenoble, France, 38000 | |
| Principal Investigator: Michèle FONTAINE | |
| Thermes La Léchère | Recruiting |
| La Léchère, France, 73260 | |
| CH Lourdes | Recruiting |
| Lourdes, France, 65100 | |
| Principal Investigator: Sylvie BADENCO | |
| Thermes Luz Saint Sauveur | Recruiting |
| Luz-Saint-Sauveur, France, 65120 | |
| Centre Léon Berard | Recruiting |
| Lyon, France, 69002 | |
| Principal Investigator: Catherine GROSSETETE, MD | |
| CH Tarbes | Recruiting |
| Tarbes, France, 65000 | |
| Principal Investigator: Fany GAYRAUD | |
| CHU Toulouse | Recruiting |
| Toulouse, France, 31059 | |
| Principal Investigator: Julie MALLOIZEL DELAUNAY | |
| Clinique générale HPDA | Recruiting |
| Valence, France, 26000 | |
| Principal Investigator: Louis DOUBLET | |
| Clinique du Tonkin | Recruiting |
| Villeurbanne, France, 69100 | |
| Principal Investigator: Anne TISSOT, MD | |
| Principal Investigator: | Patrick CARPENTIER, MD | Hospital University Grenoble |
| Responsible Party: | Association Francaise pour la Recherche Thermale |
| ClinicalTrials.gov Identifier: | NCT03580109 |
| Other Study ID Numbers: |
THERMOEDEME |
| First Posted: | July 9, 2018 Key Record Dates |
| Last Update Posted: | January 6, 2021 |
| Last Verified: | January 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lymphoedema Post breast cancer Spa therapy Education therapeutic |
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Lymphedema Lymphatic Diseases |