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Trial record 18 of 288 for:    Lymphedema

Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment (ELOCS)

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ClinicalTrials.gov Identifier: NCT02506530
Recruitment Status : Recruiting
First Posted : July 23, 2015
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
LPG SYSTEMS
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
This study will assess the benefit of LPG Cellu M6 in addition of intensive decongestive treatment in reducing secondary lymphoedema in breast cancer.

Condition or disease Intervention/treatment Phase
Lymphedema Procedure: intensive decongestive treatment Device: Cellu M6 Not Applicable

Detailed Description:

The main objective of the study is to assess the proportion of successfully treated patients (success rate).

That is to say patients having a reduction of excess arm volume ≥ 30% after 5 days of three types of treatment for secondary lymphoedema :

Group 1: standard intensive decongestive therapy for 5 days (bandages + manual lymphatic drainage).

Group 2: standard intensive decongestive therapy (bandages + manual lymphatic drainage) + Cellu M6 for 5 days Group 3: Bandages + Cellu M6 for 5 days

Symptomatic treatment of lymphoedema reference is intensive decongestive therapy including manual lymphatic drainage, compression of multicomponent bandaging, therapeutic exercise and skin care (HAS 2012 ISL International Society of Lymphology, 2013).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contribution of an Endermologie LPG Cellu M6 Treatment in the Treatment Pathway of Patients Suffering From a Breast Cancer Related Lymphoedema, During an Intensive Decongestive Treatment.
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: intensive decongestive treatment (IDT)
Patients will receive an intensive decongestive treatment for 5 days
Procedure: intensive decongestive treatment
intensive decongestive treatment

Experimental: IDT + Cellu M6
Patients will receive an intensive decongestive treatment + Cellu M6 for 5 days
Procedure: intensive decongestive treatment
intensive decongestive treatment

Device: Cellu M6
Use of Cellu M6

Active Comparator: Cellu M6 + bandages
Patients will receive an bandages + Cellu M6 for 5 days
Device: Cellu M6
Use of Cellu M6




Primary Outcome Measures :
  1. The proportion of patients successfully treated (reduction of the excessive volume in the arm>30%) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression of the excessive volume in the arm since hospitalization [ Time Frame: 6 months ]
  2. assess adverse effects [ Time Frame: 6 months ]

Other Outcome Measures:
  1. cost effectiveness analysis of treatments [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from a lymphoedema consequence of a breast cancer of grades 2 or 3 (ISL)
  • Patients suffering from Lymphoedema for 6 months or more
  • Patients with a difference between arms >10%
  • Patients who had ever had an axillary node dissection
  • Patients hospitalized for intensive standard treatment.

Exclusion Criteria:

  • Primary lymphoedema
  • Venous insufficiency of the upper members
  • severe arterial obstruction
  • obliterating arteritis of the upper limbs
  • Bilateral lymphoedema
  • Breast cancer recurrence
  • Another cancer in treatment
  • Decompensated heart failure
  • Pacemaker
  • acute infection
  • Deep venous thrombosis
  • Skin atrophy of the upper member
  • Bullous dermatosis
  • Acute dermatitis with epidermitis or dermatitis-hypodermitis
  • Infected wound
  • Inflammatory scar or consequence of a recent surgery (<1 month)
  • Presence of osteosynthesis equipment under the skin with an external part in the upper member to treat
  • Hyperalgesia of the shoulder
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506530


Contacts
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Contact: Julie MALLOIZEL-DELAUNAY, MD 05 61 32 30 33 ext +33 malloizel-delaunay.j@chu-toulouse.fr
Contact: Marianne LESCOUZERES 05 61 77 72 08 ext +33 lescouzeres.m@chu-toulouse.fr

Locations
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France
MALLOIZEL DELAUNAY Julie Recruiting
Toulouse, Midi Pyrenees, France, 31059
Contact: Julie MALLOIZEL DELAUNAY, MD    05 61 32 30 33 ext +33    malloizel-delaunay.j@chu-toulouse.fr   
Principal Investigator: Julie MALLOIZEL DELAUNAY, MD         
Sub-Investigator: Charlotte VAYSSE, MD         
Sponsors and Collaborators
University Hospital, Toulouse
LPG SYSTEMS
Investigators
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Principal Investigator: Julie MALLOIZEL-DELAUNAY, MD University Hospital, Toulouse