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Comparison of the effect of pranayama breathing exercise and conventional treatment on symptom burden in women with breast cancer undergoing chemotherapy

Protocol summary

Study aim
The impact of pranayama breathing exercises on symptom burden in breast cancer patients undergoing chemotherapy
Design
The current study is a single blind, parallel group clinical trial with a pre- and post-intervention design, which will be conducted on women with breast cancer undergoing chemotherapy referred to the educational center of the Velaiat.
Settings and conduct
This study will be carried out at the cancer department of the Qazvin City Health Center, focusing on breast cancer patients undergoing chemotherapy. To ensure blinding, a researcher other than the principal investigator will complete the questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of breast cancer (new cases), Women aged 18 years and older, Undergoing at least one cycle of chemotherapy Patients with stage one to three breast cancer, Patients who have undergone chemotherapy after breast surgery, Reading and writing literacy, Willingness to participate in the study, Performance scale of 0 to 2 Exclusion criteria: Suffering from other diseases concurrently (heart diseases, respiratory diseases, liver diseases, etc.), Undergoing radiotherapy concurrently, Being pregnant or breastfeeding concurrently, Having a history of mental illnesses or taking psychiatric drugs
Intervention groups
The intervention group will undergo pranayama breathing exercises. The intervention comprises Kapalabhati and Nadi Shudana breathing exercises, including a warm-up, Kapalabhati breathing, and Nadi Shodhana. Each training set involves four sets with 30-second rests, totaling four minutes. The control group will receive routine treatment only.
Main outcome variables
Functional status; symptom severity; dysfunction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231212060343N1
Registration date: 2024-01-23, 1402/11/03
Registration timing: registered_while_recruiting

Last update: 2024-01-23, 1402/11/03
Update count: 0
Registration date
2024-01-23, 1402/11/03
Registrant information
Name
Sima Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
sima.mohebbi6859@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of pranayama breathing exercise and conventional treatment on symptom burden in women with breast cancer undergoing chemotherapy
Public title
The impact of pranayama breathing exercises on the symptom burden of breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of breast cancer (new cases) Women 18 years and older Passing at least one cycle of chemotherapy Patients with stage one to three breast cancer Patients who have undergone chemotherapy after breast surgery Being literate in reading and writing Willingness to participate in the study Having a performance scale of 0 to 2
Exclusion criteria:
Simultaneously suffering from other diseases (heart diseases, respiratory diseases, liver diseases, etc.) Radiotherapy at the same time Concomitant pregnancy or breastfeeding History of mental illness or psychotropic drug use
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
  • Investigator
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be divided into two groups: test and control. This allocation will be achieved through random block allocation. Blocking and sequencing of samples will be conducted using random allocation software (Random Allocation Software, Version 1.0.0). To maintain the confidentiality of the random allocation process, group names will be placed inside numbered envelopes. These envelopes will be numbered in sequence by the software and organized in a box. The researcher responsible for random allocation will remain unaware of the envelope contents. Each envelope will denote the assigned study group (intervention or control). Once the sample is confirmed to have entered the research and written consent is obtained, the first envelope will be numbered. Based on its contents, the envelope will assign the participant to one of the study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
To maintain blinding, a collaborating researcher, unaware of patient allocation to control and intervention groups, will complete the questionnaires.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Qazvin University of Medical Sciences
Street address
University of Medical Sciences Headquarters, Building No. 1, Office Complex, Shahid Salmani St., North Nawab St., Qazvin.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2023-12-11, 1402/09/20
Ethics committee reference number
IR.QUMS.REC.1402.262

Health conditions studied

1

Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
symptom burden
Timepoint
Before and after intervention
Method of measurement
Eastern cooperative oncology group performance status rating (ECOG) and (M. D. Anderson Symptom Inventory (MDASI)

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, the researcher will guide patients through pranayama breathing exercises step by step during the initial face-to-face meeting in the clinic, which occurs before the commencement of chemotherapy. Group interventions, involving 3 to 5 participants, will take place for 15 to 20 minutes in a quiet and peaceful room within the chemotherapy department. Patients, and any accompanying companions, will be instructed, and video materials will be provided for additional support. Participants are expected to practice breathing exercises at home for 10 minutes twice a day over 21 days, starting one week before the initiation of chemotherapy until the 14th day after its commencement. The researcher will conduct daily phone calls to ensure participants are adhering to the home-based exercises and to monitor their health status. A diary will be designed in table format to record the time of each patient's breathing exercise, along with the frequency and type performed during the 21 days. Kapalabati and Nadi Shavana breathing exercises will be implemented in this study.
Category
Rehabilitation

2

Description
Control group: Breast cancer patients undergoing chemotherapy will receive routine treatment.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The educational and therapeutic center of the Velaiat affiliated to Qazvin University of Medical Sc
Full name of responsible person
Sima Mohebbi
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3336 4650
Fax
+98 28 3334 1934
Email
sima.mohebbi6859@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashmi
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3332 4970
Email
sima.mohebbi6859@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sima Mohebbi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 9569
Email
sima.mohebbi6859@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sima Mohebbi
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3332 4970
Email
sima.mohebbi6859@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Sima Mohebbi
Position
Master student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Bahnar Boulevard
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3332 4970
Email
sima.mohebbi6859@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Undecided - It is not yet known if there will be a plan to make this available
When the data will become available and for how long
Undecided - It is not yet known if there will be a plan to make this available
To whom data/document is available
Undecided - It is not yet known if there will be a plan to make this available
Under which criteria data/document could be used
Undecided - It is not yet known if there will be a plan to make this available
From where data/document is obtainable
Undecided - It is not yet known if there will be a plan to make this available
What processes are involved for a request to access data/document
Undecided - It is not yet known if there will be a plan to make this available
Comments
Undecided - It is not yet known if there will be a plan to make this available
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