Using Pranayama and Deep Breathing Exercises to Reduce Cancer-Related Fatigue and Insomnia During Radiotherapy

NCT04441827 | Completed DMC

• 1 other identifier: UPDBERCRFIDR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effectiveness of pranayama and deep breathing exercise in reducing fatigue and insomnia in patients receiving radiotherapy due to breast cancer. The randomized controlled interventional study was carried out with 60 patients divided into the pranayama (20), deep breathing exercise (20) and control group (20). Data were collected with the Piper Fatigue Scale (PFS), the Pittsburgh Sleep Quality Index (PSQI) and the Visual Analog Scale (VAS).

Conditions

Breast Cancer; Fatigue; Insomnia

Keywords

Breast cancer; Fatigue; Insomnia; Pranayama; Radiotherapy; Breathing exercises

Outcome Measures

Primary Outcomes (16)

• Fatigue Visual Analog Scale (VAS) Score

  This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

  Before radiotherapy

• Fatigue Visual Analog Scale (VAS) Score

  This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

  First week

• Fatigue Visual Analog Scale (VAS) Score

  This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

  Second week

• Fatigue Visual Analog Scale (VAS) Score

  This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

  Third week

• Fatigue Visual Analog Scale (VAS) Score

  This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

  Fourth week

• Fatigue Visual Analog Scale (VAS) Score

  This scale which evaluates the severity of fatigue, was scored as follows: no fatigue= 0 points, mild fatigue= 1-3 points, moderate fatigue= 4-6 points, severe fatigue= 7-9 points and unbearable fatigue= 10 points.

  Fifth week

• İnsomnia Visual Analog Scale (VAS) Score

  The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

  Before radiotherapy

• İnsomnia Visual Analog Scale (VAS) Score

  The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

  First week

• İnsomnia Visual Analog Scale (VAS) Score

  The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

  Second week

• İnsomnia Visual Analog Scale (VAS) Score

  The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

  Third week

• İnsomnia Visual Analog Scale (VAS) Score

  The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

  Fourth week

• İnsomnia Visual Analog Scale (VAS) Score

  The scoring system of this scale was as follows: no insomnia= 0 points, mild insomnia= 1-3 points, moderate insomnia= 4-6 points, severe insomnia= 7-9 points and unbearable insomnia= 10 points.

  Fifth week

• Piper Fatique Scale

  Piper Fatique Scale scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.

  Before radiotherapy

• Piper Fatique Scale

  Piper Fatique Scale consisted of 22 items and evaluated the patient's subjective fatigue perception with four subdimensions. Each item was scored between 0 and 10. A high score obtained from the scale indicated a high level of perceived fatigue.

  Fifth week

• Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas

  Before radiotherapy

• Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index is a self-report-based screening and evaluation tool that provides detailed information on sleep quality and type and severity of sleep disorder in the past month.The total PSQI score could vary from 0 to 21. A PSQI score over 5 points indicated that the person suffered serious problems in at least two areas related to sleep or that they suffered mild to moderate problems in more than three areas

  Fifth week

Study Arms (3)

Control

NO INTERVENTION

Usual care

Pranayama

EXPERIMENTAL

Pranayama breathing exercise

Other: breathing exercise

Deep breathing exercise

EXPERIMENTAL

Deep breathing exercise

Other: breathing exercise

Interventions

breathing exercise OTHER

Pranayama Group Breathing Exercises Step One:Focusing on breathing (1 minute) Step Two: Alternative nasal breathing (3 minutes) Step Three: Refreshing breath (3 minutes) Step Four: Humming bee breath (2 minutes) Step Five: Focusing on breathing (1 minute)

Deep breathing exercise; Pranayama

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 18 years,
• who underwent breast resection or modified radical mastectomy,
• were planned for radiotherapy for the chest wall/breast and lymphatic area, had Stage II-III breast cancer according to the TNM (Tumor diameter, Node, Metastasis) classification system,
• had a hemoglobin (HgB) level of 10 gm/dL and above,
• scored 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) Performance Scale
• who agreed to participate in the study were included in the sample.

You may not qualify if:

• having any problems that would prevent communication,
• having stage IV breast cancer according to the TNM classification system,
• using opioids or sedating drugs,
• scoring above 1 on the ECOG Performance Scale,
• having psychiatric illnesses,
• taking yoga/pranayama/deep breathing exercise lessons before or having done these exercises prior to diagnosis,
• having recurrent breast cancer
• being unable to perform the exercises due to physical inability/respiratory distress.

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

Ankara Yildirim Beyazıt University

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

• Messer S, Oeser A, Wagner C, Wender A, Cryns N, Scherer RW, Mishra SI, Monsef I, Holtkamp U, Andreas M, Brockelmann PJ, Ernst M, Skoetz N. Yoga for fatigue in people with cancer. Cochrane Database Syst Rev. 2025 May 27;5(5):CD015520. doi: 10.1002/14651858.CD015520.

  PMID: 40421669 DERIVED

• Gundogdu F, Kocasli S. The Effects of Pranayama or Deep Breathing Exercises on Fatigue and Sleep Quality in Women Receiving Radiation Therapy for Breast Cancer. Oncol Nurs Forum. 2023 Jun 15;50(4):509-520. doi: 10.1188/23.ONF.509-520.

  PMID: 37677752 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Fatigue; Sleep Initiation and Maintenance Disorders

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 22, 2020
• Study Start: June 1, 2017
• Primary Completion: May 15, 2018
• Study Completion: January 31, 2019
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)