Spa Therapy for Upper or Lower Limb Lymphoedema

NCT03580109 | Recruiting DMC

• 1 other identifier: THERMOEDEME
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 13

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 education program in daily life of patients suffering lymphoedema.

Conditions

Lymphoedema; Breast Cancer; Malignant Disease; Gynaecological Cancer; Lymphoma; Prostate Cancer

Keywords

Lymphoedema; Post breast cancer; Spa therapy; Education therapeutic; Malignant Disease; Post gynaecological cancer; Post Lymphoma; Post prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (14)

• Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy.

  6 and 12 months

• Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy.

  6 and 12 months

• Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema).

  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)

  6 and 12 months

• Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L

  6 and 12 months

Study Arms (2)

Immediate spa treatment

ACTIVE COMPARATOR

Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts

Other: Immediate spa treatment

Late spa treatment

SHAM COMPARATOR

Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization

Other: Late spa treatment

Interventions

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)

Immediate spa treatment

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)

Late spa treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Francaise pour la Recherche Thermale: lead
• Floralis: collaborator

Study Sites (13)

Cabinet de médecine vasculaire

Albertville, 73200, France

RECRUITING

CHU Amiens Picardie

Amiens, 80054, France

RECRUITING

Thermes Argelès-Gazost

Argelès-Gazost, 65400, France

RECRUITING

Thermes Barbotan Les Bains

Barbotan-les-Thermes, 32150, France

RECRUITING

Groupe Hospitalier Mutualiste

Grenoble, 38000, France

RECRUITING

Thermes La Léchère

La Léchère, 73260, France

RECRUITING

CH Lourdes

Lourdes, 65100, France

RECRUITING

Thermes Luz Saint Sauveur

Luz-Saint-Sauveur, 65120, France

RECRUITING

Centre Léon Berard

Lyon, 69002, France

RECRUITING

CH Tarbes

Tarbes, 65000, France

RECRUITING

CHU Toulouse

Toulouse, 31059, France

RECRUITING

Clinique générale HPDA

Valence, 26000, France

RECRUITING

Clinique du Tonkin

Villeurbanne, 69100, France

RECRUITING

Related Publications (16)

• 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.

  PMID: 18519968 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.

  PMID: 12926833 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.

  PMID: 24135621 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.

  PMID: 23212603 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.

  PMID: 19807551 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.

  PMID: 12719681 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.

  PMID: 20924341 BACKGROUND

• Lymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54.

  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.

  PMID: 22296831 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.

  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.

  PMID: 11319415 BACKGROUND

• Blaise S, Villemur B, Richaud C, Rastel D, Bucci B, Evra V, Bouchet JY, les membres du réseau GRANTED, B.Satger. Conception d'un programme d'éducation thérapeutique pour les patients porteurs de lymphoedème : " Vivre avec un lymphoedème ". J Mal Vasc 2011,online access : doi:10.1016/j.jmv.2011.10.006

  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.

  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.

  PMID: 37073384 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

  BACKGROUND

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms; Lymphoma; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Patrick CARPENTIER, MD

  Hospital University Grenoble

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator doesn't know the group of randomization of the patient. The spa therapy organisation is managed by the coordination center.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups: * Immediate spa therapy: the patient carries out the spa therapy with education therapeutic soon after the enrolment in the study * Late spa therapy: the patient carries out the spa therapy with education therapeutic after the 6-month follow up

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 9, 2018
• Study Start: June 20, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

FR (13)