LymphoedemaTHERMOEDEMENCT03580109
Spa Therapy for Upper or Lower Limb Lymphoedema
A study testing Immediate spa treatment and Late spa treatment in people with Lymphoedema and Breast Cancer, run by Association Francaise pour la Recherche Thermale at 13 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphoedema, Breast Cancer, Malignant Disease
- What is being tested?
- Immediate spa treatment and Late spa treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 13 sitesFrance
- Study dates
- 20 Jun 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- risk of intensive treatment in the next 6 months
- subject participating to an other clinical study interventional
- pregnancy, parturient or breast feeding
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites, 13 recruiting
- Recruiting
Cabinet de médecine vasculaire
Albertville, 73200
Michèle VIONNET FUASSET, MD
- Recruiting
CHU Amiens Picardie
Amiens, 80054
Simon SOUDET
- Recruiting
Thermes Argelès-Gazost
Argelès-Gazost, 65400
- Recruiting
Thermes Barbotan Les Bains
Barbotan-les-Thermes, 32150
- Recruiting
Groupe Hospitalier Mutualiste
Grenoble, 38000
Michèle FONTAINE
- Recruiting
Thermes La Léchère
La Léchère, 73260
- Recruiting
CH Lourdes
Lourdes, 65100
Sylvie BADENCO
- Recruiting
Thermes Luz Saint Sauveur
Luz-Saint-Sauveur, 65120
- Recruiting
Centre Léon Berard
Lyon, 69002
Catherine GROSSETETE, MD
- Recruiting
CH Tarbes
Tarbes, 65000
Fany GAYRAUD
- Recruiting
CHU Toulouse
Toulouse, 31059
Julie MALLOIZEL DELAUNAY
- Recruiting
Clinique générale HPDA
Valence, 26000
Louis DOUBLET
- Recruiting
Clinique du Tonkin
Villeurbanne, 69100
Anne TISSOT, MD
About this study
Official title: Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
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.
Read the 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 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).
- Conditions
- Lymphoedema, Breast Cancer, Malignant Disease, Gynaecological Cancer, Lymphoma, Prostate Cancer
- Being tested
- Immediate spa treatment, Late spa treatment
- Keywords
- Lymphoedema, Post breast cancer, Spa therapy, Education therapeutic, Malignant Disease, Post gynaecological cancer, Post Lymphoma, Post prostate cancer
- Medical subject headings
- Lymphedema, Breast Neoplasms, Lymphoma, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate spa treatmentOther
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 treatmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Immediate spa treatment | Active comparator | Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts Receives: Other: Immediate spa treatment |
| Late spa treatment | Sham comparator | Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization Receives: Other: Late spa treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 6 and 12 months
Compliance of spa therapy
Evaluation of the spa therapy compliance : number of health care performed in spa therapy.
Measured: After spa therapy
Achievement educational aims
Verification of the achievement of educational targets in spa therapy by phone follow up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Effect size
Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start20 Jun 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for LymphoedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- Floralis
- Responsible party
- Sponsor
- Investigators
- Patrick CARPENTIER, MD, Principal investigator, Hospital University Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580109
- Sponsor's protocol ID
- THERMOEDEME
- Acronym
- THERMOEDEME
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18519968International 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.
PubMed 12926833Carpentier 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.
PubMed 24135621Pusic 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.
PubMed 23212603Norman 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.
PubMed 19807551Norman 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.
PubMed 12719681Devoogdt 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.
PubMed 20924341Lymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54.
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.
PubMed 22296831Carpentier 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, 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.
PubMed 11319415Blaise 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.
PubMed 22196687Carpentier 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.
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.
PubMed 37073384
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
- ClinicalTrials.gov ID
- NCT03580109
- Acronym / sponsor ID
- THERMOEDEME / THERMOEDEME
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- Floralis
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Immediate spa treatment | Active comparator | Other: Immediate spa treatmentSpa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts |
| Late spa treatment | Sham comparator | Other: Late spa treatmentSpa treatment linked with education therapeutic during 18 days 6 months visit after randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate spa treatmentSpa 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) | Other | Immediate spa treatment |
| Late spa treatmentSpa 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) | Other | Late spa treatment |
Primary outcome
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema).
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 (worse outcome) to 5 (better outcome). The higher the score is, the better the lymphoedema quality of life is.
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LYMQOL-LEG scale (for lower limb lymphoedema).
Time frame: 6 months
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.
14 secondary outcomes
Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy.
Time frame: 6 and 12 months
Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy.
Time frame: 6 and 12 months
Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema).
Time frame: 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)
Time frame: 6 and 12 months
Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L
Time frame: 6 and 12 months
Upper or lower limb evaluation
Time frame: 6 and 12 months
Consumption of care between the 2 groups (immediate treatment/delayed treatment)
Time frame: 6 and 12 months
Compliance of spa therapy
Time frame: After spa therapy
Achievement educational aims
Time frame: 3 months, 9 months.
Adverse events
Time frame: 12 months
Functional evaluation
Time frame: 12 months
Long term evaluation
Time frame: 12 months
Effect size
Time frame: 6 and 12 months
Sub group analysis
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 18519968Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014.
- Background: PubMed 12926833International 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.
- Background: PubMed 24135621Carpentier 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.
- Background: PubMed 23212603Pusic 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.
- Background: PubMed 19807551Norman 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.
- Background: PubMed 12719681Norman 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.
- Background: PubMed 20924341Devoogdt 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.
- BackgroundLymphœdema Framework. Best Practice for the Management of Lymphœdema. International consensus. London: MEP Ltd, 2006:1-54.
- Background: PubMed 22296831Vignes 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.
- BackgroundCarpentier PH, Fabry R. Crénothérapie des maladies vasculaires. In: Queneau P, editor. Médecine Thermale, faits et preuves. Paris: Masson Ed; 2000. p. 102-15.
- Background: PubMed 11319415Carpentier 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.
- Background: PubMed 22196687Blaise 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick CARPENTIER, MD principal investigator
Hospital University Grenoble
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate spa treatment and Late spa treatment in people with Lymphoedema and Breast Cancer, run by Association Francaise pour la Recherche Thermale at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexa COMTE (334 76 76 66 39, alexa.comte@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema). (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03580109, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.