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Spa Therapy for Upper or Lower Limb Lymphoedema (THERMOEDEME)

Primary Purpose

Lymphoedema, Breast Cancer, Malignant Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immediate spa treatment
Late spa treatment
Sponsored by
Association Francaise pour la Recherche Thermale
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lymphoedema focused on measuring Lymphoedema, Post breast cancer, Spa therapy, Education therapeutic, Malignant Disease, Post gynaecological cancer, Post Lymphoma, Post prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet de médecine vasculaireRecruiting
  • CHU Amiens PicardieRecruiting
  • Thermes Argelès-GazostRecruiting
  • Thermes Barbotan Les BainsRecruiting
  • Groupe Hospitalier MutualisteRecruiting
  • Thermes La LéchèreRecruiting
  • CH LourdesRecruiting
  • Thermes Luz Saint SauveurRecruiting
  • Centre Léon BerardRecruiting
  • CH TarbesRecruiting
  • CHU ToulouseRecruiting
  • Clinique générale HPDARecruiting
  • Clinique du TonkinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Immediate spa treatment

Late spa treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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)
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.
Consumption of care between the 2 groups (immediate treatment/delayed treatment)
Evaluation of the costs incurred by lymphoedema (hospitalisations, medical and paramedical acts, treatments).
Compliance of spa therapy
Evaluation of the spa therapy compliance : number of health care performed in spa therapy.
Achievement educational aims
Verification of the achievement of educational targets in spa therapy by phone follow up.
Adverse events
Evaluation of all adverse events related to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials.
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.
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.
Effect size
Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.
Sub group analysis
Sub group analysis on the primary outcome measure (stratification on primo spa therapy, lymphoedema severity and lymphoedema localization)

Full Information

First Posted
June 5, 2018
Last Updated
May 10, 2023
Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
Floralis
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1. Study Identification

Unique Protocol Identification Number
NCT03580109
Brief Title
Spa Therapy for Upper or Lower Limb Lymphoedema
Acronym
THERMOEDEME
Official Title
Spa Therapy for Upper or Lower Limb Lymphoedema : a Randomized and Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Francaise pour la Recherche Thermale
Collaborators
Floralis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
The investigator doesn't know the group of randomization of the patient. The spa therapy organisation is managed by the coordination center.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate spa treatment
Arm Type
Active Comparator
Arm Description
Spa treatment linked with education therapeutic during 18 days just after randomization : common to all of spa resorts
Arm Title
Late spa treatment
Arm Type
Sham Comparator
Arm Description
Spa treatment linked with education therapeutic during 18 days 6 months visit after randomization
Intervention Type
Other
Intervention Name(s)
Immediate spa treatment
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Late spa treatment
Intervention Description
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 Measure Information:
Title
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LMS27 scale (for upper limb lymphoedema).
Description
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.
Time Frame
6 months
Title
Evolution of lymphoedema quality of life assessed by the rate of patient with an improvement of the LYMQOL-LEG scale (for lower limb lymphoedema).
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Evolution of lymphoedema quality of life assessed by the LMS27 scale (for upper limb lymphoedema) before / after spa therapy.
Description
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.
Time Frame
6 and 12 months
Title
Evolution of lymphoedema quality of life assessed by the LYMQOL-LEG scale (for lower limb lymphoedema) before / after spa therapy.
Description
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.
Time Frame
6 and 12 months
Title
Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LMS27 scale (for upper lymphoedema).
Description
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.
Time Frame
6 and 12 months
Title
Evolution of lymphoedema quality of life assessed by the most embarrassing items of the LYMQOL-LEG scale (for lower limb lymphoedema)
Description
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.
Time Frame
6 and 12 months
Title
Improvement of quality of life assessed by the generic quality of life: Euroquol EQ5D-3L
Description
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)
Time Frame
6 and 12 months
Title
Upper or lower limb evaluation
Description
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.
Time Frame
6 and 12 months
Title
Consumption of care between the 2 groups (immediate treatment/delayed treatment)
Description
Evaluation of the costs incurred by lymphoedema (hospitalisations, medical and paramedical acts, treatments).
Time Frame
6 and 12 months
Title
Compliance of spa therapy
Description
Evaluation of the spa therapy compliance : number of health care performed in spa therapy.
Time Frame
After spa therapy
Title
Achievement educational aims
Description
Verification of the achievement of educational targets in spa therapy by phone follow up.
Time Frame
3 months, 9 months.
Title
Adverse events
Description
Evaluation of all adverse events related to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials.
Time Frame
12 months
Title
Functional evaluation
Description
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.
Time Frame
12 months
Title
Long term evaluation
Description
Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.
Time Frame
12 months
Title
Effect size
Description
Confirmation of the extent of the effect between 6 and 12 months on the primary outcome and secondary outcomes.
Time Frame
6 and 12 months
Title
Sub group analysis
Description
Sub group analysis on the primary outcome measure (stratification on primo spa therapy, lymphoedema severity and lymphoedema localization)
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexa COMTE
Phone
334 76 76 66 39
Email
alexa.comte@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Carole ROLLAND
Phone
334 76 76 69 03
Email
carole.rolland@univ-grenoble-alpes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick CARPENTIER, MD
Organizational Affiliation
Hospital University Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet de médecine vasculaire
City
Albertville
ZIP/Postal Code
73200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michèle VIONNET FUASSET, MD
Facility Name
CHU Amiens Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon SOUDET
Facility Name
Thermes Argelès-Gazost
City
Argelès-Gazost
ZIP/Postal Code
65400
Country
France
Individual Site Status
Recruiting
Facility Name
Thermes Barbotan Les Bains
City
Barbotan-les-Thermes
ZIP/Postal Code
32150
Country
France
Individual Site Status
Recruiting
Facility Name
Groupe Hospitalier Mutualiste
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michèle FONTAINE
Facility Name
Thermes La Léchère
City
La Léchère
ZIP/Postal Code
73260
Country
France
Individual Site Status
Recruiting
Facility Name
CH Lourdes
City
Lourdes
ZIP/Postal Code
65100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie BADENCO
Facility Name
Thermes Luz Saint Sauveur
City
Luz-Saint-Sauveur
ZIP/Postal Code
65120
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Léon Berard
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine GROSSETETE, MD
Facility Name
CH Tarbes
City
Tarbes
ZIP/Postal Code
65000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fany GAYRAUD
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie MALLOIZEL DELAUNAY
Facility Name
Clinique générale HPDA
City
Valence
ZIP/Postal Code
26000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis DOUBLET
Facility Name
Clinique du Tonkin
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne TISSOT, MD

12. IPD Sharing Statement

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Spa Therapy for Upper or Lower Limb Lymphoedema

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