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

NCT05754346 | Completed

• 1 other identifier: bakircaymzeren07
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema, Breast Cancer; Lymphedema of Upper Limb

Outcome Measures

Primary Outcomes (1)

• Change from baseline lymphedema volume at 6th week

  Arm volume will be measured using water displacement method.

  6 weeks

Secondary Outcomes (2)

• Change from baseline upper extremity pain at 6th week

  6 weeks

• Change from baseline quality of life at 6th week

  6 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Study Group

EXPERIMENTAL

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; Other: Upper extremity exercises combined with diaphragmatic breathing exercises

Interventions

Complete Decongestive Therapy OTHER

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.

Control Group; Study Group

Upper extremity exercises combined with diaphragmatic breathing exercises OTHER

"Upper-extremity exercises" component of Complete Decongestive Therapy will be performed combined with diaphragmatic breathing exercises.

Study Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Bezmialem Vakif University: collaborator
• Istanbul Kent University: collaborator

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alis Kostanoglu, assoc.prof.

  Bezmialem Vakif University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asst. prof.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: March 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)