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

NCT03945838 | Completed

• 1 other identifier: LymphHG
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema Arm; Lymphedema; Surgical

Keywords

Lymphedema; Hand grip strength; Breast cancer related lymphedema; Complete decongestion therapy

Outcome Measures

Primary Outcomes (2)

• Hand grip strength

  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.

  3 weeks

• Extremity volume

  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.

  3 weeks

Study Arms (1)

Breast cancer related lymphedema

All patients were included in the complete decongestive therapy programme. This therapy includes patient education, skin care, exercises, manual lymphatic drainage (self), and compression bandage therapy.

Other: Complete Decongestion Therapy

Interventions

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.

Breast cancer related lymphedema

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18-70 years old with a history of mastectomy or breast conserving surgery and lymphedema * Having a certain diagnosis of lymphedema

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege university school of medicine

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher in Ege University School of Medicine

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: April 4, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)