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OpenTrials
Completed

NCT Number: NCT05754346

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

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.

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Key information

Conditions

Lymphedema, Breast Cancer Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Lymphedema of Upper Limb Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline lymphedema volume at 6th week

    Time frame: 6 weeks

    Arm volume will be measured using water displacement method.

Secondary outcomes

  1. Change from baseline upper extremity pain at 6th week

    Time frame: 6 weeks

    Visual analog scale will be used for for quantifying pain.

  2. Change from baseline quality of life at 6th week

    Time frame: 6 weeks

    Quality of life will be evaluated using Lymphedema Functioning, Disability and Health Questionnaire for Upper Limb Lymphedema.

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Collaborators

  • Bezmialem Vakif University
  • Istanbul Kent University

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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