Lymphedema of Upper ArmNCT03492476
Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema
A study testing Circaid and Short-stretching Bandage (Reference treatment) in people with Lymphedema of Upper Arm, run by CEN Biotech at 4 sites in France.
Trial summary
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphedema of Upper Arm
- What is being tested?
- Circaid and Short-stretching Bandage (Reference treatment)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Sep 2017to 2 Mar 2022
- 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
- be women over the age of 18;
- presenting a unilateral lymphedema of the upper limb of stage II or III according to the International Society of Lymphology, secondary to the curative ganglion treatment of a cancer, whatever its nature, and requiring a decongestive treatment by contention / compression;
- presenting an increase in the volume of the arm affected by lymphedema of at least 10% when compared to the contralateral arm;
- benefiting of the French health insurance coverage;
- duly informed of the benefits, constraints and risks of the study;
- medically and legally able to understand the methods of carrying out the study and to give written informed consent to participate in the study;
- having given their free written informed consent to their participation in the study
Who cannot join
- Not be included in the study:
- from a medical point of view, the patients:
- with stage I lymphedema;
- with lymphedema of multiple locations;
- having had intensive decongestive treatment in the last 6 months;
- having a recurrence of cancer or a peripheral arterial disease contraindicating or restraining compression.
Show all 10Show fewer
- from a legal point of view, the patients:
- not in a position to give free and informed consent because of an administrative or judicial decision or a pathology that may affect their judgment or a difficulty of linguistic comprehension;
- currently participating in another clinical trial or in an exclusion period from another clinical trial;
- who may not adhere to the terms of the protocol.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
Chu Saint Eloi
Montpellier, 34295
Ghr Mulhouse Sud Alsace
Mulhouse, 68070
Hopital Cognacq Jay
Paris, 75015
About this study
Official title: Controlled, Randomized Clinical Trial of the Circaid® Compression Sleeve Versus Short-stretching Bandage at the Reduction Phase of Upper Limb Lymphatic Edema and Versus Compression Sleeve and Short-stretching Bandages at the Initial Maintenance Phase
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.
The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.
Read the detailed description
During the intensive decongestive treatment phase, which usually takes place in specialized lymphedema treatment departments, the staff are properly trained and have the required experience, but the appliance of these short-length compression bandages requires a lot of time. During the maintenance phase, the appliance of short stretch bandages gives way during the day to the wearing of a compression sleeve which can be put on fairly easily. But during the night, in the absence of a nurse or a spouse with the technical skills required to put them in place, few patients can benefit from the wearing of short stretching bandages. During the maintenance phase, many patients quickly give up these nocturnal bandages, thus losing the gain obtained during the reduction phase. This situation is all the more regrettable that, as shown in the studies, this nocturnal wearing contributes to a very significant reduction in the rate of reappearance of lymphedema and avoids the recurrent need of intensive reduction sessions in hospitals, which are costly for health insurance. and uncomfortable for the patients.
To improve this situation, medi has developed a device called circaid®, consisting of non-elastic bands adjustable and repositionable with "Velcro" systems, which can be used both for the intensive reduction phase but also during the maintenance phase by the patients themselves because of its ease of placement.
It is composed of several inelastic strips or removable straps, parallel and overlapping slightly to leave no crease and no space between them. Velcro tabs or fasteners help ensure proper initial positioning and readjustment as the arm volume is reduced. This gives a given pressure by tightening or loosening each band while limiting friction and discomfort. In the intensive reduction phase, its ease of use reduces the time devoted by nurses to the use of short stretching tapes which, in addition to the need for good technique, requires a significant amount of time. In the maintenance phase, this original and comfortable compression device allows the patient to become autonomous after minimal learning. The simplicity of the introduction of the system on the limb and the calibration of the delivered pressure allows to develop the self management of the treatment, because it is possible to reposition the bands as and when the decrease of the edema, which makes it possible to optimize the effectiveness of the treatment. The ability to instantly readjust the circaid®Juxtafit system allows to constantly apply the right level of pressure delivered, to reduce the volume of the limb. This is not possible with a traditional multilayer bandage if the different layers are not completely remove. A visual calibrator ensures the right level of pressure delivered at all times.
In addition to efficiency, patients' quality of life is improved by being able to remove and return it on their own, making it easier to wash or dress. Similarly, less rigid while being just as compressive, it allows a better comfort in the daily gestures and in particular to have a normal range of arm flexion movements more compatible with driving than the wearing of tapes.
The product is currently marketed in many countries and is reimbursed in the following countries: United States, Quebec, the Netherlands, United Kingdom, Austria in the indication of the treatment of lymphedema.
In view of its admission to reimbursement in France, a meeting was held with HAS experts in the context of the so-called early meeting procedure in order to define the study that should be done. A detailed synopsis which is the one of the present protocol has been validated by the methodological experts of the HAS as being able to bring the arguments of effectiveness required by being as close as possible to the usual practice and by covering at the same time the phase of intensive reduction and the maintenance phase. It aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.
- Conditions
- Lymphedema of Upper Arm
- Being tested
- Circaid, Short-stretching Bandage (Reference treatment)
- Keywords
- Lymphedema of Upper Arm reduction, Lymphedema Upper Arm device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircaidDevice
Also called Non-elastic bands
Three observation periods were defined with the following products:
- D1 to D5: intensive hospital treatment performed by the night and day wearing of the circaid® compression system
- Day of Discharge (DD) from the hospital to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime compression system circaid®
- DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime circaid® compression system
Short-stretching Bandage (Reference treatment)Device
Also called Non-elastic bands
Three observation periods were defined with the following products:
- D1 to D5: intensive hospital treatment performed by the night and day wearing of short stretching tapes.
- DD (Day of discharge from the hospital) to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with a possible treatment at night, as recommended by HAS.
- DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with possible treatment at night
| Study group | Role | What they receive |
|---|---|---|
| Circaid | Experimental | Compression sleeve on the day associated with the night wearing of the system of contention circaid® Receives: Device: Circaid |
| Reference treatment | Active comparator | Compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the HAS Receives: Device: Short-stretching Bandage (Reference treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction of upper limb lymphatic edema D30
The main objective of the study is to compare, at the 30th day of the initial maintenance phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the wearing of a compression sleeve on the day associated with the night wearing of the system of contention circaid® versus the wearing of a compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the french High Authority of Health (HAS).
Measured: 30 days
Secondary outcomes (15)
Volume reduction of upper limb lymphatic edema D5
To compare, on the 5th day of the reduction phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the night and day wearing of the circaid® compression system and the night and day wearing of short lengthening bands such as recommended by the HAS
Measured: 5 days
Volume reduction of upper limb lymphatic edema D90
To compare, at the 90th day of the maintenance phase, the reduction in the volume of lymphatic edema maintained by the wearing of a compression sleeve during the day associated with the circaid® compression system at night and the wearing of a compression sleeve during the day associated with a possible wearing at night.
Measured: 90 days
Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression)
To compare, at the 5th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the Clinical Global Improvement Impression (CGII). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
Measured: 5 days
Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression)
To compare, at the 5th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the Patient Global Improvement Impression (PGII). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
Measured: 5 days
Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression)
To compare, at the 30th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the PGII (Patient Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
Measured: 30 days
Patient's opinion on lymphedema-induced discomfort improvement D90 (Patient Global Improvement Impression)
To compare, at the 90th day of the reduction phase the patient's opinions on lymphedema-induced discomfort improvement through the PGII (Patient Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
Measured: 90 days
Physician's opinion on lymphedema-induced discomfort improvement D30 (Clinical Global Improvement Impression)
To compare, at the 30th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the CGII (Clinical Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
Measured: 30 days
Physician's opinion on lymphedema-induced discomfort improvement D90 (Clinical Global Improvement Impression)
To compare, at the 90th day of the reduction phase the physicians' opinions on lymphedema-induced discomfort improvement through the CGII (Clinical Global Improvement Impression). The evaluation focuses on the change in the volume of lymphoedema. The scale has 7 levels: from "Significantly decreased" (better outcome) to "Significantly increased" (worse outcome). Intermediate levels are: "Much decreased"; "Slightly decreased", "No change"; "Slightly increased"; "Much increased".
Measured: 90 days
Patient's satisfaction about efficiency of the treatment D30 (Likert scale)
To compare, at the 30th day of the initial maintenance phase the patient's satisfaction. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all efficient" (worse outcome) to "Very efficient" (better outcome). Intermediate levels are: "A bit"; "Moderately"; "Efficient".
Measured: 30 days
Patient's satisfaction about wearing comfort of the treatment D30 (Likert scale)
To compare, at the 30th day of the initial maintenance phase the patient's wearing comfort experienced. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all comfortable" (worse outcome) to "Very comfortable" (better outcome). Intermediate levels are:"A bit"; "Moderately"; "Comfortable".
Measured: 30 days
Patient's satisfaction about efficiency of the treatment D90 (Likert scale)
To compare, at the 90th day of the initial maintenance phase the patient's satisfaction. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all efficient" (worse outcome) to "Very efficient" (better outcome). Intermediate levels are: "A bit"; "Moderately"; "Efficient".
Measured: 30 days
Patient's satisfaction about wearing comfort of the treatment D90 (Likert scale)
To compare, at the 90th day of the initial maintenance phase the patient's wearing comfort experienced. Patient assesses her satisfaction on a 5 items Likert scale from "Not at all comfortable" (worse outcome) to "Very comfortable" (better outcome). Intermediate levels are:"A bit"; "Moderately"; "Comfortable".
Measured: 90 days
Patient's opinions on the ease of use of the product D90 (6 items to be completed by the patient)
To compare, at the 90th day of the initial maintenance phase the patients' opinions on the ease of use of the product. The patient have to complete 6 items (Yes/no response) : "Did you need caregiver's help ?"; "Did you need a third party to install the device ?"; "Did you have difficulty applying the required pressures ?"; "Do you wish to continue using the device ?"; "Would you recommend this device to third parties ?"; "Does the device seem easy to use ?".
Measured: 30 days
Tolerance of the different products (patient evaluation on self-administered questionnaire)
To compare the tolerance of the different products at different phases of reduction and maintenance. Evaluation item on patient self-administered questionnaire "Intolerance to the device" to be assessed every week (Yes/no response, if yes, the patient have to precise).
Measured: 90 days
Quality of patient's life assessment with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF)
The quality of patient's life is assessed at each visit (D0, D5, D30, D90) with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF).
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start8 Sep 2017
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lymphedema of Upper ArmStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEN Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- medi
- Responsible party
- Sponsor
- Investigators
- MARLENE COUPE, MD, Study chair, University Hospital, MontpellierERIC MARTIN, M., Study director, medi France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492476
- Sponsor's protocol ID
- C1512
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2018
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012 Oct 20;30(30):3726-33. doi: 10.1200/JCO.2012.41.8574. Epub 2012 Sep 24.
PubMed 23008299Leone N, Voirin N, Roche L, Binder-Foucard F, Woronoff AS, Delafosse P, Remontet L, Bossard N, Uhry Z. Projection de l'incidence et de la mortalité par cancer en France métropolitaine en 2015. Rapport technique. Saint-Maurice (Fra): Institut de veille sanitaire, 2015. 62 p
Grosclaude P, Remontet L, Belot A, Danzon A, Rasamimanana C, Bossard N. Survie des personnes atteintes de cancer en France, 1989-2007 - Etude à partir des registres des cancers du réseau Francim. Saint-Maurice: Institut de veille sanitaire; 2013. 412 p
Hayes SC, Janda M, Cornish B, Battistutta D, Newman B. Lymphedema after breast cancer: incidence, risk factors, and effect on upper body function. J Clin Oncol. 2008 Jul 20;26(21):3536-42. doi: 10.1200/JCO.2007.14.4899.
PubMed 18640935Campbell KL, Pusic AL, Zucker DS, McNeely ML, Binkley JM, Cheville AL, Harwood KJ. A prospective model of care for breast cancer rehabilitation: function. Cancer. 2012 Apr 15;118(8 Suppl):2300-11. doi: 10.1002/cncr.27464.
PubMed 22488704Velanovich V, Szymanski W. Quality of life of breast cancer patients with lymphedema. Am J Surg. 1999 Mar;177(3):184-7; discussion 188. doi: 10.1016/s0002-9610(99)00008-2.
PubMed 10219851Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH, Elting LS. Incidence, treatment costs, and complications of lymphedema after breast cancer among women of working age: a 2-year follow-up study. J Clin Oncol. 2009 Apr 20;27(12):2007-14. doi: 10.1200/JCO.2008.18.3517. Epub 2009 Mar 16.
PubMed 19289624Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006
Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, and compression devices. Semin Oncol Nurs. 2013 Feb;29(1):28-40. doi: 10.1016/j.soncn.2012.11.005.
PubMed 23375064Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.
PubMed 24931830Lymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012
Vignes S, Porcher R, Arrault M, Dupuy A. Factors influencing breast cancer-related lymphedema volume after intensive decongestive physiotherapy. Support Care Cancer. 2011 Jul;19(7):935-40. doi: 10.1007/s00520-010-0906-x. Epub 2010 May 22.
PubMed 20495983
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled, Randomized Clinical Trial of the Circaid® Compression Sleeve Versus Short-stretching Bandage at the Reduction Phase of Upper Limb Lymphatic Edema and Versus Compression Sleeve and Short-stretching Bandages at the Initial Maintenance Phase
- ClinicalTrials.gov ID
- NCT03492476
- Acronym / sponsor ID
- C1512
- Conditions
- Lymphedema of Upper Arm
- Keywords
- Lymphedema of Upper Arm reduction, Lymphedema Upper Arm device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- CEN BiotechIndustry (pharma, biotech, devices)
- Collaborators
- medi
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 10 Apr 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.
One of the difficulties encountered in the treatment of lymphedema, both in the active reduction phase and in the maintenance phase, is the appliance of the short-length compression bandages which requires good technicality and experience to exert the pressure required to remove liquids from tissue spaces and reduce the volume of the arm or prevent it from increasing again.
The study aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.
Detailed description
During the intensive decongestive treatment phase, which usually takes place in specialized lymphedema treatment departments, the staff are properly trained and have the required experience, but the appliance of these short-length compression bandages requires a lot of time. During the maintenance phase, the appliance of short stretch bandages gives way during the day to the wearing of a compression sleeve which can be put on fairly easily. But during the night, in the absence of a nurse or a spouse with the technical skills required to put them in place, few patients can benefit from the wearing of short stretching bandages. During the maintenance phase, many patients quickly give up these nocturnal bandages, thus losing the gain obtained during the reduction phase. This situation is all the more regrettable that, as shown in the studies, this nocturnal wearing contributes to a very significant reduction in the rate of reappearance of lymphedema and avoids the recurrent need of intensive reduction sessions in hospitals, which are costly for health insurance. and uncomfortable for the patients.
To improve this situation, medi has developed a device called circaid®, consisting of non-elastic bands adjustable and repositionable with "Velcro" systems, which can be used both for the intensive reduction phase but also during the maintenance phase by the patients themselves because of its ease of placement.
It is composed of several inelastic strips or removable straps, parallel and overlapping slightly to leave no crease and no space between them. Velcro tabs or fasteners help ensure proper initial positioning and readjustment as the arm volume is reduced. This gives a given pressure by tightening or loosening each band while limiting friction and discomfort. In the intensive reduction phase, its ease of use reduces the time devoted by nurses to the use of short stretching tapes which, in addition to the need for good technique, requires a significant amount of time. In the maintenance phase, this original and comfortable compression device allows the patient to become autonomous after minimal learning. The simplicity of the introduction of the system on the limb and the calibration of the delivered pressure allows to develop the self management of the treatment, because it is possible to reposition the bands as and when the decrease of the edema, which makes it possible to optimize the effectiveness of the treatment. The ability to instantly readjust the circaid®Juxtafit system allows to constantly apply the right level of pressure delivered, to reduce the volume of the limb. This is not possible with a traditional multilayer bandage if the different layers are not completely remove. A visual calibrator ensures the right level of pressure delivered at all times.
In addition to efficiency, patients' quality of life is improved by being able to remove and return it on their own, making it easier to wash or dress. Similarly, less rigid while being just as compressive, it allows a better comfort in the daily gestures and in particular to have a normal range of arm flexion movements more compatible with driving than the wearing of tapes.
The product is currently marketed in many countries and is reimbursed in the following countries: United States, Quebec, the Netherlands, United Kingdom, Austria in the indication of the treatment of lymphedema.
In view of its admission to reimbursement in France, a meeting was held with HAS experts in the context of the so-called early meeting procedure in order to define the study that should be done. A detailed synopsis which is the one of the present protocol has been validated by the methodological experts of the HAS as being able to bring the arguments of effectiveness required by being as close as possible to the usual practice and by covering at the same time the phase of intensive reduction and the maintenance phase. It aims to compare the current protocol of care considered optimal for the reduction of lymphedema and the maintenance of this reduction with the protocol of care which would integrate the device circaid® in substitution to the laying of bands with short extension as it is now in other countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circaid | Experimental | Device: CircaidCompression sleeve on the day associated with the night wearing of the system of contention circaid® |
| Reference treatment | Active comparator | Device: Short-stretching Bandage (Reference treatment)Compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the HAS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be women over the age of 18;
- presenting a unilateral lymphedema of the upper limb of stage II or III according to the International Society of Lymphology, secondary to the curative ganglion treatment of a cancer, whatever its nature, and requiring a decongestive treatment by contention / compression;
- presenting an increase in the volume of the arm affected by lymphedema of at least 10% when compared to the contralateral arm;
- benefiting of the French health insurance coverage;
- duly informed of the benefits, constraints and risks of the study;
Key exclusion criteria (10 listed)
- from a medical point of view, the patients:
- from a legal point of view, the patients:
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 |
|---|---|---|
| CircaidAlso: Non-elastic bandsThree observation periods were defined with the following products: * D1 to D5: intensive hospital treatment performed by the night and day wearing of the circaid® compression system * Day of Discharge (DD) from the hospital to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime compression system circaid® * DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime circaid® compression system | Device | Circaid |
| Short-stretching Bandage (Reference treatment)Also: Non-elastic bandsThree observation periods were defined with the following products: * D1 to D5: intensive hospital treatment performed by the night and day wearing of short stretching tapes. * DD (Day of discharge from the hospital) to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with a possible treatment at night, as recommended by HAS. * DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with possible treatment at night | Device | Reference treatment |
Primary outcome
Volume reduction of upper limb lymphatic edema D30
Time frame: 30 days
The main objective of the study is to compare, at the 30th day of the initial maintenance phase, the reduction in the volume of lymphatic edema of the upper limb obtained under the effect of the wearing of a compression sleeve on the day associated with the night wearing of the system of contention circaid® versus the wearing of a compression sleeve during the day associated with a possible treatment with it during the night, according to the recommendations of the french High Authority of Health (HAS).
15 secondary outcomes
Volume reduction of upper limb lymphatic edema D5
Time frame: 5 days
Volume reduction of upper limb lymphatic edema D90
Time frame: 90 days
Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression)
Time frame: 5 days
Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression)
Time frame: 5 days
Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression)
Time frame: 30 days
Patient's opinion on lymphedema-induced discomfort improvement D90 (Patient Global Improvement Impression)
Time frame: 90 days
Physician's opinion on lymphedema-induced discomfort improvement D30 (Clinical Global Improvement Impression)
Time frame: 30 days
Physician's opinion on lymphedema-induced discomfort improvement D90 (Clinical Global Improvement Impression)
Time frame: 90 days
Patient's satisfaction about efficiency of the treatment D30 (Likert scale)
Time frame: 30 days
Patient's satisfaction about wearing comfort of the treatment D30 (Likert scale)
Time frame: 30 days
Patient's satisfaction about efficiency of the treatment D90 (Likert scale)
Time frame: 30 days
Patient's satisfaction about wearing comfort of the treatment D90 (Likert scale)
Time frame: 90 days
Patient's opinions on the ease of use of the product D90 (6 items to be completed by the patient)
Time frame: 30 days
Tolerance of the different products (patient evaluation on self-administered questionnaire)
Time frame: 90 days
Quality of patient's life assessment with the Lymphoedema Functioning, Disability and Health questionnaire (Lymph-ICF)
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 23008299Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedema risk factors, diagnosis, treatment, and impact: a review. J Clin Oncol. 2012 Oct 20;30(30):3726-33. doi: 10.1200/JCO.2012.41.8574. Epub 2012 Sep 24.
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- BackgroundFramework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006
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- BackgroundLymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012
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- Individual participant dataSharing planned: No
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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.
MARLENE COUPE, MD study chair
University Hospital, Montpellier
ERIC MARTIN, M. study director
medi France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circaid and Short-stretching Bandage (Reference treatment) in people with Lymphedema of Upper Arm, run by CEN Biotech at 4 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume reduction of upper limb lymphatic edema D30 (time frame: 30 days). 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 NCT03492476, which also lists 12 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 2 Mar 2023.