Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Sykehuset Telemark100 enrolled

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Secondary Lymphedema Breast Cancer

Interventions

SurgeryPROCEDURE

Lymphovenous anastomosis

Compression and drainage therapyOTHER

Treatment with compression stockings and manual drainage (massage therapy)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Sykehuset Telemark

Skien, Telemark, Norway

RECRUITING

Outcomes

Primary Outcomes

Volume

Volume of arm as described by submersion and circumference measures

Time frame: 12 months

Secondary Outcomes

Health related quality of life ULL27

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.

Time frame: 12 months

Central Contacts

Lars Johan Sandberg, MD

CONTACT

+4735003456 johansandberg@hotmail.com

Data from ClinicalTrials.gov

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