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Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Primary Purpose

Secondary Lymphedema, Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Surgery

Compression and drainage therapy

About this trial

This is an interventional treatment trial for Secondary Lymphedema focused on measuring Lymphovenous bypass, Lymphovenous anastomosis, Supermicrosurgery, Lymphangiography, MD Anderson Lymphedema Stage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sykehuset TelemarkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgery

Compression

Arm Description

Lymphovenous anastomosis

Conservative treatment with physiotherapy and compression

Outcomes

Primary Outcome Measures

Volume

Volume of arm as described by submersion and circumference measures

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03578380

First Posted

June 12, 2017

Last Updated

April 15, 2023

Sponsor

Sykehuset Telemark

Collaborators

University of Oslo, Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT03578380

Brief Title

Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2016 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sykehuset Telemark

Collaborators

University of Oslo, Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Lymphedema, Breast Cancer

Keywords

Lymphovenous bypass, Lymphovenous anastomosis, Supermicrosurgery, Lymphangiography, MD Anderson Lymphedema Stage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Experimental

Arm Description

Lymphovenous anastomosis

Arm Title

Compression

Arm Type

Active Comparator

Arm Description

Conservative treatment with physiotherapy and compression

Intervention Type

Procedure

Intervention Name(s)

Surgery

Intervention Description

Lymphovenous anastomosis

Intervention Type

Other

Intervention Name(s)

Compression and drainage therapy

Intervention Description

Treatment with compression stockings and manual drainage (massage therapy)

Primary Outcome Measure Information:

Title

Volume

Description

Volume of arm as described by submersion and circumference measures

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Health related quality of life ULL27

Description

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lars Johan Sandberg, MD

Phone

+4735003456

johansandberg@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Johan Sandberg, MD

Organizational Affiliation

Sykehuset Telemark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sykehuset Telemark

City

Skien

State/Province

Telemark

ZIP/Postal Code

NO-3710

Country

Norway

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to share IPD with other researchers

Learn more about this trial

Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

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