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Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

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ClinicalTrials.gov Identifier: NCT03578380
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
University of Oslo
Ohio State University
Information provided by (Responsible Party):
Sykehuset Telemark

Tracking Information
First Submitted Date  ICMJE June 12, 2017
First Posted Date  ICMJE July 6, 2018
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE January 26, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2018)
Volume [ Time Frame: 12 months ]
Volume of arm as described by submersion and circumference measures
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2018)
Health related quality of life ULL27 [ Time Frame: 12 months ]
To be measured by questionnaire "Upper Limb Lymphedema score 27" (ULL27) by Professor Robert Launois at REES France. The scale measures health related quality of life in patients with upper limb lymphedema. Construction: 27 questions rated from 1 (lowest quality of life) to 5 highest quality of life. Dimensions: There are 3 dimensions assessing symptoms, self value, everyday social life. Total score 27-135 Symptom score: 18-90 Self value: 5-25 Social life: 4-20 Question 20 and 22 are part of the self value dimension and are control questions with reverse scores, i.e 1 represents highest quality of life and 5 represents lowest quality of life. The scores for question 20 and 22 are later reversed when adding the total score.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supermicrosurgery for Breast Cancer Survivors With Lymphedema.
Official Title  ICMJE Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.
Brief Summary A randomised prospective investigation of volume and quality of life results with lymphovenous anastomosis in patients with unilateral arm lymphedema after breast cancer using Indocyanine Green lymphangiography and MD Anderson Staging.
Detailed Description This is a randomized study comparing lymphovenous anastomosis versus conservative (compression) treatment for lymphoedema after breast cancer surgery - 50 patients to be included in each study arm. The primary endpoint is volume change measured by submersion and changes in arm circumference at defined levels from the wrist. Secondary endpoint is health related quality of life measured by questionnaire Short Form 36 (SF-36), Hospital Anxiety Depression Score (HADS), Fatigue Questionnaire (FQ) and a disease-specific questionnaire, Upper Limb Lymphedema score (ULL27).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Secondary Lymphedema
  • Breast Cancer
Intervention  ICMJE
  • Procedure: Surgery
    Lymphovenous anastomosis
  • Other: Compression and drainage therapy
    Treatment with compression stockings and manual drainage (massage therapy)
Study Arms  ICMJE
  • Experimental: Surgery
    Lymphovenous anastomosis
    Intervention: Procedure: Surgery
  • Active Comparator: Compression
    Conservative treatment with physiotherapy and compression
    Intervention: Other: Compression and drainage therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unilateral lymphedema of the arm secondary to breast cancer treatment. Stage 1-3 operable lymphedema.

Exclusion Criteria:

  • Frequent or severe cellulitis. All other lymphedema.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lars Johan Sandberg, MD +4735003456 johansandberg@hotmail.com
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03578380
Other Study ID Numbers  ICMJE Prosjektnr 1097.19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers
Responsible Party Sykehuset Telemark
Study Sponsor  ICMJE Sykehuset Telemark
Collaborators  ICMJE
  • University of Oslo
  • Ohio State University
Investigators  ICMJE
Principal Investigator: Lars Johan Sandberg, MD Sykehuset Telemark
PRS Account Sykehuset Telemark
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP