Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Overview

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.

Full Title of Study: “Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

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).

Interventions

  • Procedure: Surgery
    • Lymphovenous anastomosis
  • Other: Compression and drainage therapy
    • Treatment with compression stockings and manual drainage (massage therapy)

Arms, Groups and Cohorts

  • Experimental: Surgery
    • Lymphovenous anastomosis
  • Active Comparator: Compression
    • Conservative treatment with physiotherapy and compression

Clinical Trial Outcome Measures

Primary Measures

  • Volume
    • Time Frame: 12 months
    • Volume of arm as described by submersion and circumference measures

Secondary Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sykehuset Telemark
  • Collaborator
    • University of Oslo
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lars Johan Sandberg, MD, Principal Investigator, Sykehuset Telemark
  • Overall Contact(s)
    • Lars Johan Sandberg, MD, +4735003456, johansandberg@hotmail.com

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