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CompletedNCT07164352Updated Sep 10, 2025

Effect of Breathing Exercises on Pain, Dyspnea, and Function in Terminal-Stage Cancer Patients

An interventional study of Breathing Exercises and Informational Brochure in Palliative Patients, Terminal Malignant Tumors and Breathing Techniques, sponsored by Atlas University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Atlas University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Aug 2024, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to evaluate the effects of supervised breathing exercises on pain, dyspnea, and functionality in terminal-stage cancer patients receiving palliative care. Participants in the intervention group receive diaphragmatic and pursed-lip breathing exercises under the guidance of a physiotherapist, while the control group receives only an educational brochure. The study compares pre- and post-intervention outcomes between both groups.

Read the detailed description

This randomized controlled trial aims to investigate the effects of diaphragmatic and pursed-lip breathing exercises on pain, dyspnea, and functional status in terminal-stage cancer patients receiving palliative care. Participants are divided into two groups: the intervention group receives supervised breathing exercises by a physiotherapist, while the control group is given an informational brochure without any physical guidance.

The primary objective is to determine whether supervised breathing exercises provide significant improvements in symptom control and functionality compared to usual care. Assessments are made before and after the intervention using validated tools including the Edmonton Symptom Assessment System (ESAS-r), the Cancer Dyspnea Scale (CDS), and the Visual Analog Scale (VAS) for pain.

The study aims to contribute to the clinical evidence supporting non-pharmacological interventions in palliative care and to offer practical approaches for improving quality of life in terminally ill cancer patients.

02

Conditions studied

  • Palliative Patients
  • Terminal Malignant Tumors
  • Breathing Techniques

Keywords

  • Palliative Care
  • Terminal Stage Cancer
  • Breathing Exercises
03

In context

Lead sponsor

Atlas University is the lead sponsor of 91 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients receiving palliative care, who are part of this treatment process and considered eligible for the study.
  • Patients diagnosed with Stage 4 cancer, included in the study due to their advanced cancer stage.
  • Patients with oxygen saturation levels below 95% in room air, who are deemed appropriate for monitoring respiratory function due to this condition.
  • Participants must be able to effectively communicate during the study period.
  • Individuals who agree to participate in the study must provide written or verbal consent, which is a mandatory criterion for ethical compliance.

Exclusion criteria

Exclusion Criteria:

  • Patients who are unconscious and unable to participate in the study. Individuals under the age of 18.
  • Patients dependent on a ventilator.
  • Patients with serious health issues, such as uncontrolled hypertension and dyspnea.
  • Patients with other significant health problems that prevent participation in the research program.
  • Patients with medical conditions requiring drainage treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist

    Participants in this arm receive supervised breathing exercises performed with a physiotherapist, focusing on diaphragmatic and pursed-lip breathing techniques.

    Behavioral: Breathing Exercises

  • Active comparator
    Brochure Education Only

    Participants in this arm receive an informational brochure that explains breathing exercises, but no supervised exercise is provided.

    Behavioral: Informational Brochure

Interventions

  • BehavioralBreathing Exercises

    Diaphragmatic and pursed-lip breathing exercises supervised by a physiotherapist.

  • BehavioralInformational Brochure

    A brochure providing education about breathing exercises for cancer patients.

06

What researchers measure

Primary outcomes

  1. dyspnea

    Dyspnea severity will be assessed using the Edmonton Symptom Assessment System - revised (ESAS-r) dyspnea item. This is a numeric rating scale ranging from 0 to 10, where 0 indicates no shortness of breath and 10 indicates the worst possible shortness of breath. The outcome will evaluate changes in dyspnea severity following a structured breathing exercise intervention.

    Time frame: From enrollment to the end of treatment at 1 weeks

  2. Functionality

    Functionality will be measured using the Edmonton Symptom Assessment System - revised (ESAS-r) physical well-being domain. The ESAS-r is a validated self-report instrument in which patients rate symptom severity on a scale from 0 to 10, with 0 indicating no impairment and 10 indicating the worst possible level of functional impairment. This outcome assesses changes in participants' ability to perform daily activities such as walking, dressing, and self-care.

    Time frame: From enrollment to the end of treatment at 1 weeks

07

Study locations

1 site
  • Eyupsultan State Hospital
    Istanbul, 34500, Turkey (Türkiye)
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 7, 2025
  • Informed consent form · Aug 7, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — This clinical trial evaluates the effects of structured respiratory exercises on pain, dyspnea, and physical functionality in terminal-stage cancer patients under palliative care. It is a single-arm interventional study with pre- and post-intervention assessments. Participants perform pursed-lip and diaphragmatic breathing exercises under physiotherapist supervision for one week. The primary outcomes are changes in pain and dyspnea, measured using ESAS-r and CDS. Secondary outcomes include functional status assessed via standardized tools. Data are collected at baseline and after the intervention. The study follows the Declaration of Helsinki and has received institutional ethical approval. Results aim to support the use of non-pharmacological methods in enhancing the quality of life for patients in end-of-life care.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07164352
Lead sponsor
Atlas University
Responsible party
Fatma Nur Yildiz (Physiotherapist, Atlas University) — Principal investigator
First posted
Sep 10, 2025
Start date
Aug 4, 2024
Primary completion
May 15, 2025
Completion
May 15, 2025
Last update
Sep 10, 2025

Study contacts

Yaşar Gül BALTACI, Prof. Dr.
study director · İstanbul Atlas University, Department of Physical Medicine and Rehabilitation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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