Assessment of Muscle Strength and Volume Changes in Patients With Breast Cancer- Related Lymphedema

This study aims to find whether complete decongestive therapy used in breast cancer-related lymphedema has an effect on muscle strength in the affected arm, while assessing the efficacy of the therapy itself. 74 patients with breast cancer related lymphedema were included in this study. Patients were taken their demographic and clinical history and were evaluated with measurements of extremity volumes and hand grip strengths using a hand dynamometer before and after the complete decongestive therapy. Data were then assessed using relevant statistical methods.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema Arm Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Lymphedema; Surgical Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Ege university school of medicine

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Having had mastectomy or breast conserving surgery
Having a certain diagnosis of lymphedema with a difference in arm circumferences more than 1 cm

Exclusion criteria

The subjects with active infection or cancer with metastases, the ones who didn't accept the complete decongestive therapy, patients with vascular disease, rheumatic disease, upper limb deformity, any upper limb surgery history, bilateral lymphedema or a history of transplantation were excluded

Treatment and study plan

Complete Decongestion Therapy

Other

It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume.

All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema.

Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments.

Primary outcomes

Hand grip strength

Time frame: 3 weeks

Hand grip strength: Hand grip strength was measured using JAMAR® hand dynamometer. It has been used to assess hand grip strength in many studies over half a century. Patients were asked to sit down with shoulder adducted, elbow flexed (90°) and forearm in the neutral position. Mean of the 3 measurements taken with 1 minute apart from each other was recorded. Patients' measurements were taken for both affected and unaffected arm, and recorded as kgf.
Extremity volume

Time frame: 3 weeks

Volume measurements were taken using ulnar styloid process as a index point, and circumferential measurements were taken with 5 cm spaces from distal to the proximal. Using a computer programme (Limb Volumes Professional version 5.0), the total volume of the arm was calculated and recorded before and after the treatment for both arms.

All patients' measurements were taken by the same researcher.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: May 10, 2019
Registry last updated: May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting