Supermicrosurgery for Breast Cancer Survivors With Lymphedema.

Sykehuset Telemark

Status: Enrolling

Conditions: Breast Cancer; Secondary Lymphedema

Treatments: Procedure: Surgery; Other: Compression and drainage therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03578380

Prosjektnr 1097.19

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Surgery

Experimental group

Description:

Lymphovenous anastomosis

Treatment:

Procedure: Surgery

Compression

Active Comparator group

Description:

Conservative treatment with physiotherapy and compression

Treatment:

Other: Compression and drainage therapy