Back to resultsDoes Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
Primary Purpose
Lymphedema, Breast Cancer, Lymphedema of Upper Limb
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Complete Decongestive Therapy
Upper extremity exercises combined with diaphragmatic breathing exercises
Sponsored by
About this trial
This is an interventional treatment trial for Lymphedema, Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Bezmialem Vakif UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Study Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change from baseline lymphedema volume at 6th week
Arm volume will be measured using water displacement method.
Secondary Outcome Measures
Change from baseline upper extremity pain at 6th week
Visual analog scale will be used for for quantifying pain.
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.
Full Information
NCT ID
NCT05754346
First Posted
February 22, 2023
Last Updated
April 6, 2023
Sponsor
Izmir Bakircay University
Collaborators
Bezmialem Vakif University, Istanbul Kent University
1. Study Identification
Unique Protocol Identification Number
NCT05754346
Brief Title
Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
Official Title
Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Bakircay University
Collaborators
Bezmialem Vakif University, Istanbul Kent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Breast Cancer, Lymphedema of Upper Limb
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Complete Decongestive Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Upper extremity exercises combined with diaphragmatic breathing exercises
Intervention Description
"Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.
Primary Outcome Measure Information:
Title
Change from baseline lymphedema volume at 6th week
Description
Arm volume will be measured using water displacement method.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline upper extremity pain at 6th week
Description
Visual analog scale will be used for for quantifying pain.
Time Frame
6 weeks
Title
Change from baseline quality of life at 6th week
Description
Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema.
Time Frame
6 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gozde Basbug, PhD
Phone
+90 535 558 89 09
Email
gozde.basbug@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alis Kostanoglu, assoc.prof.
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Study Director
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gozde Basbug, PhD
Phone
+90 535 558 89 09
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
We'll reach out to this number within 24 hrs