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Clinical Trials/NCT05754346
NCT05754346CompletedNot Applicable

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

Izmir Bakircay University1 site in 1 country40 target enrollmentStarted: March 20, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Change from baseline lymphedema volume at 6th week

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change from baseline lymphedema volume at 6th week

Time Frame: 6 weeks

Arm volume will be measured using water displacement method.

Secondary Outcomes

  • Change from baseline upper extremity pain at 6th week(6 weeks)
  • Change from baseline quality of life at 6th week(6 weeks)

Investigators

Sponsor
Izmir Bakircay University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Melih Zeren

asst. prof.

Izmir Bakircay University

Study Sites (1)

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