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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05754346
Other study ID # bakircaymzeren07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2023
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Izmir Bakircay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 65 Years
Eligibility 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


Intervention

Other:
Complete Decongestive Therapy
Complete Decongestive Therapy will include manual lymphedema drainage (self) for 20 min everyday, skin care everyday, wearing compression garment or bandages everyday and upper-extremity exercises twice a day.
Upper extremity exercises combined with diaphragmatic breathing exercises
"Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Izmir Bakircay University Bezmialem Vakif University, Istanbul Kent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline lymphedema volume at 6th week Arm volume will be measured using water displacement method. 6 weeks
Secondary Change from baseline upper extremity pain at 6th week Visual analog scale will be used for for quantifying pain. 6 weeks
Secondary Change from baseline quality of life at 6th week Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema. 6 weeks
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