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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lymphedema, Breast Cancer, Lymphedema of Upper Limb

Intervention / Treatment
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* Other: Complete Decongestive Therapy
* Other: Upper extremity exercises combined with diaphragmatic breathing exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>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. | Other: Complete Decongestive Therapy<br>* 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.<br>|
| Experimental: Study Group<br>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. | Other: Complete Decongestive Therapy<br>* 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.<br>Other: Upper extremity exercises combined with diaphragmatic breathing exercises<br>* Upper-extremity exercises component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline lymphedema volume at 6th week | Arm volume will be measured using water displacement method. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline upper extremity pain at 6th week | Visual analog scale will be used for for quantifying pain. | 6 weeks | 
| 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 |