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| Name | Class |
|---|---|
| Floralis | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate spa treatment | Active Comparator | Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts |
|
| Late spa treatment | Sham Comparator | Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate spa treatment | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Patrick CARPENTIER, MD | Hospital University Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet de médecine vasculaire | Recruiting | Albertville | 73200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18519968 | Background | Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014. | |
| 12926833 | Background | International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema. Consensus document of the International Society of Lymphology. Lymphology. 2003 Jun;36(2):84-91. |
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2 groups:
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The investigator doesn't know the group of randomization of the patient. The spa therapy organisation is managed by the coordination center.
| Late spa treatment | Other | 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) |
|
| 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. | 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. | 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. | 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) | 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. | 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). | 6 and 12 months |
| Compliance of spa therapy | Evaluation of the spa therapy compliance : number of health care performed in spa therapy. | After spa therapy |
| Achievement educational aims | Verification of the achievement of educational targets in spa therapy by phone follow up. | 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. | 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. | 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. | 12 months |
| Effect size | Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes. | 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) | 6 months |
| CHU Amiens Picardie | Recruiting | Amiens | 80054 | France |
|
| Thermes Argelès-Gazost | Recruiting | Argelès-Gazost | 65400 | France |
| Thermes Barbotan Les Bains | Recruiting | Barbotan-les-Thermes | 32150 | France |
| Groupe Hospitalier Mutualiste | Recruiting | Grenoble | 38000 | France |
|
| Thermes La Léchère | Recruiting | La Léchère | 73260 | France |
| CH Lourdes | Recruiting | Lourdes | 65100 | France |
|
| Thermes Luz Saint Sauveur | Recruiting | Luz-Saint-Sauveur | 65120 | France |
| Centre Léon Berard | Recruiting | Lyon | 69002 | France |
|
| CH Tarbes | Recruiting | Tarbes | 65000 | France |
|
| CHU Toulouse | Recruiting | Toulouse | 31059 | France |
|
| Clinique générale HPDA | Recruiting | Valence | 26000 | France |
|
| Clinique du Tonkin | Recruiting | Villeurbanne | 69100 | France |
|
| 24135621 | Background | Carpentier PH, Blaise S, Satger B, Genty C, Rolland C, Roques C, Bosson JL. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency. J Vasc Surg. 2014 Feb;59(2):447-454.e1. doi: 10.1016/j.jvs.2013.08.002. Epub 2013 Oct 15. |
| 23212603 | Background | Pusic AL, Cemal Y, Albornoz C, Klassen A, Cano S, Sulimanoff I, Hernandez M, Massey M, Cordeiro P, Morrow M, Mehrara B. Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes. J Cancer Surviv. 2013 Mar;7(1):83-92. doi: 10.1007/s11764-012-0247-5. Epub 2012 Dec 5. |
| 19807551 | Background | Norman GR, Sloan JA, Wyrwich KW. The truly remarkable universality of half a standard deviation: confirmation through another look. Expert Rev Pharmacoecon Outcomes Res. 2004 Oct;4(5):581-5. doi: 10.1586/14737167.4.5.581. |
| 12719681 | Background | Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C. |
| 20924341 | Background | Devoogdt N, Lemkens H, Geraerts I, Van Nuland I, Flour M, Coremans T, Christiaens MR, Van Kampen M. A new device to measure upper limb circumferences: validity and reliability. Int Angiol. 2010 Oct;29(5):401-7. |
| Background | Lymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54. |
| 22296831 | Background | Vignes S. [Management of limb lymphedema]. Rev Med Interne. 2012 May;33(5):268-72. doi: 10.1016/j.revmed.2011.12.012. Epub 2012 Jan 31. French. |
| Background | Carpentier PH, Fabry R. Crénothérapie des maladies vasculaires. In: Queneau P, editor. Médecine Thermale, faits et preuves. Paris: Masson Ed; 2000. p. 102-15. |
| 11319415 | Background | Carpentier PH, Colomb M, Poensin D, Satger B. [Incidence of erysipelas of the lower limbs in a spa resort. Efficacy of a strategy of sanitation education (La Lechere: 1992-1997)]. J Mal Vasc. 2001 Apr;26(2):97-9. French. |
| 22196687 | Background | Blaise S, Villemur B, Richaud C, Rastel D, Bucci B, Evra V, Bouchet JY, Satger B; Reseau GRANTED. [Designing a therapeutic education program for patients with lymphedema: live with lymphedema]. J Mal Vasc. 2012 Feb;37(1):1-8. doi: 10.1016/j.jmv.2011.10.006. Epub 2011 Dec 21. French. |
| Background | 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) |
| Background | Launois R, Alliot F. Quality of Life Scale in Upper Limb Lymphoedema - A validation Study. Lymphology 33, 2000 (Suppl) : 266-74. |
| 37073384 | Background | Lim P, Li H, Neoh D, Ng SK. Health-related Quality of Life Measurement Tools for Lymphedema: A Review of the Literature. Plast Reconstr Surg Glob Open. 2022 Apr 27;10(4):e4276. doi: 10.1097/GOX.0000000000004276. eCollection 2022 Apr. |
| Background | Keeley, Vaughan; Crooks, Sue; Locke, Jane; Veigas, Debbie; Riches, Katie and Hilliam, Rachel (2010). A quality of life measure for limb lymphoedema (LYMQOL). Journal of Lymphoedema, 5(1) pp. 26-37 |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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