Circaid® Compression Sleeve Versus Short-stretching Bandage in Upper Limb Lymphatic Edema

NCT03492476 | Completed

• 1 other identifier: C1512
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Lymphedema of Upper Arm

Keywords

Lymphedema of Upper Arm reduction; Lymphedema Upper Arm device

Outcome Measures

Primary Outcomes (1)

• 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).

  30 days

Secondary Outcomes (15)

• Volume reduction of upper limb lymphatic edema D5

  5 days

• Volume reduction of upper limb lymphatic edema D90

  90 days

• Physician's opinion on lymphedema-induced discomfort improvement D5 (Clinical Global Improvement Impression)

  5 days

• Patient's opinion on lymphedema-induced discomfort improvement D5 (Patient Global Improvement Impression)

  5 days

• Patient's opinion on lymphedema-induced discomfort improvement D30 (Patient Global Improvement Impression)

  30 days

Study Arms (2)

Circaid

EXPERIMENTAL

Compression sleeve on the day associated with the night wearing of the system of contention circaid®

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

Device: Short-stretching Bandage (Reference treatment)

Interventions

Circaid DEVICE

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

Also known as: Non-elastic bands

Circaid

Short-stretching Bandage (Reference treatment) DEVICE

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

Also known as: Non-elastic bands

Reference treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female only can be recruited.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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;
• who may not adhere to the terms of the protocol.

Sponsors & Collaborators

• CEN Biotech: lead
• medi: collaborator

Study Sites (4)

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33300, France

Location

Chu Saint Eloi

Montpellier, 34295, France

Location

Ghr Mulhouse Sud Alsace

Mulhouse, 68070, France

Location

Hopital Cognacq Jay

Paris, 75015, France

Location

Related Publications (12)

• 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.

  PMID: 23008299 BACKGROUND

• Leone 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 18640935 BACKGROUND

• Campbell 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.

  PMID: 22488704 BACKGROUND

• Velanovich 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.

  PMID: 10219851 BACKGROUND

• Shih 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.

  PMID: 19289624 BACKGROUND

• Framework L. Best practice for the management of lymphoedema: an international consensus. London: MEP Ltd; 2006

  BACKGROUND

• 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.

  PMID: 23375064 BACKGROUND

• Quere 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.

  PMID: 24931830 BACKGROUND

• Lymphoedema Framework International consensus. Best Practice for the management of Lymphoedema London: MEP Ltd, 2006 and 2nd Edition 2012

  BACKGROUND

• 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.

  PMID: 20495983 BACKGROUND

Study Officials

• MARLENE COUPE, MD

  University Hospital, Montpellier

  STUDY CHAIR

• ERIC MARTIN, M.

  medi France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 10, 2018
• Study Start: September 8, 2017
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)