Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema

Not Applicable

Completed

• Conditions: Lymphedema, Breast Cancer; Lymphedema of Upper Limb
• Interventions: Other: Complete Decongestive Therapy; Other: Upper extremity exercises combined with diaphragmatic breathing exercises

• Registration Number: NCT05754346
• Lead Sponsor: Izmir Bakircay University

Brief Summary

Complete decongestive therapy is proven to be effective in reducing lymphedema related symptoms such as swelling and pain. Breathing exercises, on the other hand, may also help managing lymphedema symptoms. Deep breathing creates a pressure change in the abdomen, which creates a vacuum effect in the thoracic cavity and helps to empty the lymphatic vessels. Thus, we aimed to investigate whether addition of diaphragmatic breathing exercises to physical exercise component of complete decongestive therapy provides further benefits on lymphedema volume, pain and quality of life in patients with breast cancer related lymphedema.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-03
• Study Start: 2023-03-20
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of arm lymphedema after being treated for unilateral breast cancer with axillary node dissection
• Completion of the treatments for the disease including chemotherapy and radiotherapy after breast surgery

Exclusion Criteria

• Having recurrent cancer
• Having cognitive disability
• Having any concurrent diseases that may interfere with the measurement of lymphedema

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Complete Decongestive Therapy	Patients in this group will receive "Complete Decongestive Therapy" for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.
Study Group	Complete Decongestive Therapy	Patients in this group will receive "Complete Decongestive Therapy" combined with diaphragmatic breathing exercises for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.
Study Group	Upper extremity exercises combined with diaphragmatic breathing exercises	Patients in this group will receive "Complete Decongestive Therapy" combined with diaphragmatic breathing exercises for 6 weeks. 1 session each week will be supervised in a clinic. Rest of the sessions will be performed at home.

Primary Outcome Measures

Name	Time	Method
Change from baseline lymphedema volume at 6th week	6 weeks	Arm volume will be measured using water displacement method.

Secondary Outcome Measures

Name	Time	Method
Change from baseline upper extremity pain at 6th week	6 weeks	Visual analog scale will be used for for quantifying pain.
Change from baseline quality of life at 6th week	6 weeks	Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema.

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey