Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

April 15, 2023 updated by: Sykehuset Telemark

Supermicrosurgery for Breast Cancer Survivors With Lymphedema. -Prospective Randomized Clinical and Patient-reported Outcomes.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Telemark
      • Skien, Telemark, Norway, NO-3710
        • Recruiting
        • Sykehuset Telemark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
Lymphovenous anastomosis
Procedure: Surgery
Lymphovenous anastomosis
Active Comparator: Compression
Conservative treatment with physiotherapy and compression
Other: Compression and drainage therapy
Treatment with compression stockings and manual drainage (massage therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume
Time Frame: 12 months
Volume of arm as described by submersion and circumference measures
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Telemark

Collaborators

University of Oslo
Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2016

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 24, 2018

First Posted (Actual)

July 6, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 15, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prosjektnr 1097.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD with other researchers

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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