Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Not Applicable

Recruiting

• Conditions: Breast Cancer; Secondary Lymphedema
• Interventions: Other: Compression and drainage therapy; Procedure: Surgery

• Registration Number: NCT03578380
• Lead Sponsor: Sykehuset Telemark

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 Timeline

• Study Start: 2016-01-26
• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2018-06-24
• Study First Posted: 2018-07-06
• Status Verified: 2022-12
• Last Update Submitted: 2023-04-15
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compression	Compression and drainage therapy	Conservative treatment with physiotherapy and compression
Surgery	Surgery	Lymphovenous anastomosis

Primary Outcome Measures

Name	Time	Method
Volume	12 months	Volume of arm as described by submersion and circumference measures

Secondary Outcome Measures

Name	Time	Method
Health related quality of life ULL27	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.

Trial Locations

Locations (1)

Sykehuset Telemark; 🇳🇴 Skien, Telemark, Norway