Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

NCT ID: NCT03578380

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-26

Study Completion Date

2024-12-31

Brief Summary

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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

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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).

Conditions

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Secondary Lymphedema Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgery

Lymphovenous anastomosis

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

Lymphovenous anastomosis

Compression

Conservative treatment with physiotherapy and compression

Group Type ACTIVE_COMPARATOR

Compression and drainage therapy

Intervention Type OTHER

Treatment with compression stockings and manual drainage (massage therapy)

Interventions

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Surgery

Lymphovenous anastomosis

Intervention Type PROCEDURE

Compression and drainage therapy

Treatment with compression stockings and manual drainage (massage therapy)

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Johan Sandberg, MD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Telemark

Locations

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Sykehuset Telemark

Skien, Telemark, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Lars Johan Sandberg, MD

Role: CONTACT

+4735003456

Other Identifiers

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Prosjektnr 1097.19

Identifier Type: -

Identifier Source: org_study_id

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