Evaluation of the Treatment Response in Breast Cancer Related Lymphedema

Ege University

Status: Completed

Conditions: Breast Cancer Lymphedema; Breast Cancer; Lymphedema of Upper Limb

Treatments: Procedure: Complete Decongtestive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04766489

CLUE-BCL

Details and patient eligibility

About

This study aims to evaluate the effects of the treatment for breast cancer lymphedema. After taking a detailed history and giving a physical examination, breast cancer related lymphedema patients(n:30) will be informed and will be given Complete Decongestive Therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise. Patients will be evaluated with limb volume, lymphedema index acquired through bioimpedance device, QuickDASH for upper extremity function, hand dynamometer for upper extremity grip strength and CLUE(Breast Cancer-Related Lymphedema of the Upper Extremity standardized clinical evaluation tool) scoring for lymphedema before and after the intervention. The values will be compared in order to show whether there are significant differences between before and after scores, and whether CLUE score is correlated with the other indicators of breast cancer related lymphedema.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral lymphedema of the arm after mastectomy for breast cancer

Exclusion criteria

• Bilateral lymphedema
• Primary bone tumor and/or metastasis
• Patients with ongoing radiotherapy
• Circulation disorders of the upper extremity(eg; peripheral vascular disease, thrombosis)
• Patients with infectious lymphedema/elephantiasis
• Presence of local infection in upper extremities(cellulitis) and/or presence of severe systemic infection
• Carcinomatous lymphangitis
• Congestive heart failure(NYHA class 3 or 4)
• History of prosthesis on upper extremities
• Use of drugs which may alter the fluid or electrolyte balance

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Complete Deongestive Therapy

Experimental group

Description:

Patients will be given complete decongestive therapy for 5 days a week and for a mean of 20 sessions. Each session will be of approximately 2 hours and 15 minutes in duration, although short stretch bandaging will be left on for 23 hours a day.

Treatment:

Procedure: Complete Decongtestive Therapy