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

NCT ID: NCT05754346

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphedema, Breast Cancer Lymphedema of Upper Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

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.

Group Type ACTIVE_COMPARATOR

Complete Decongestive Therapy

Intervention Type 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.

Study Group

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.

Group Type EXPERIMENTAL

Complete Decongestive Therapy

Intervention Type 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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Upper extremity exercises combined with diaphragmatic breathing exercises

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role collaborator

Istanbul Kent University

OTHER

Sponsor Role collaborator

Izmir Bakircay University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melih Zeren

asst. prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alis Kostanoglu, assoc.prof.

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bakircaymzeren07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.