| CTRI Number |
CTRI/2021/04/033040 [Registered on: 23/04/2021] Trial Registered Prospectively |
| Last Modified On: |
22/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of yoga on heart and lung functions in breast cancer patients receiving radiotherapy |
|
Scientific Title of Study
|
Effect of structured yoga therapy on cardiometabolic and respiratory functions and quality of life in breast cancer patients following post-mastectomy radiotherapy: An interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G K Pal |
| Designation |
Professor (Senior Scale) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Physiology,
1st floor
JIPMER Academic Center,
JIPMER, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344291160 |
| Fax |
|
| Email |
drgkpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G K Pal |
| Designation |
Professor (Senior Scale) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Physiology,
1st floor
JIPMER Academic Center,
JIPMER, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344291160 |
| Fax |
|
| Email |
drgkpal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Anjali |
| Designation |
M.Sc. Student (PG student) |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of Physiology,
1st floor
JIPMER Academic Center,
JIPMER, Gorimedu, Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8920663181 |
| Fax |
|
| Email |
anjalijha031@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, Puducherry, INDIA |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education Research JIPMER |
| Address |
Dhanvantari Nagar,
Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G K Pal |
JIPMER |
Dept of Radiation Oncology
Regional Cancer Centre Block
JIPMER
Dhanvantari Nagar
Puducherry 605006
Pondicherry
PONDICHERRY |
9344291160
drgkpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Intervention |
Breast cancer without yoga |
| Intervention |
Yoga |
The participants in the study group will undergo yoga therapy along with the conventional radiotherapy. The yoga sessions will be conducted by certified Yoga trainers for 5 days a week for 6 weeks. The yoga module will include asanas and pranayamas. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Stage II, III Female breast cancer patients under- going radiotherapy following modified radical mastectomy.
2. Female breast cancer patients in a position to
receive yoga therapy.
3. Performance status - ECOG (0,1) grade |
|
| ExclusionCriteria |
| Details |
1.Patients with recurrent malignancies or other co-existing malignancies.
2. Those who had received prior radiation to the
chest wall was also excluded from the study.
3. Patients with confounding factors such as diabetes mellitus and hypertension.
4. Patients who were on drugs that modulate the
autonomic nervous system. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of yoga on cardiometabolic, oxidative stress and inflammatory markers, and pulmonary functions in female breast cancer patients following post-mastectomy radiotherapy.
2. To assess the effect of yoga on quality of life and psychological functions in female breast cancer patients following post-mastectomy radiotherapy. |
2 time points
Initially as soon as the subjects are recruited and
2nd time assessment will be done after 6 weeks of yoga intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the general health of the breast cancer patients following yoga |
1 time point
Assessment will be done after 6 weeks of yoga intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Female breast cancer patients those who meet the inclusion and exclusion criteria will be explained about the study. After obtaining written informed consent, the participants will be recruited into one among the two groups. Study participants will be asked to report to the Department of Physiology, JIPMER Academic Center then, their demographic details including age, marital, educational and occupational status, menstrual and obstetric history of the participants will be obtained. History of medical conditions, drug intake, history pertaining to breast cancer diagnosis and the treatment undertaken will be noted. Then lung functions, changes in heart rate and blood pressure will be recorded which will take around 30 minutes. Five ml of venous blood will be collected for estimation of biochemical tests for assessing heart function. Study group participants will undergo yoga therapy along with the radiotherapy. The yoga sessions will be conducted by certified yoga trainers in the ACYTER for 5 days a week for 6 weeks. The yoga module will include some asanas and pranayamas approximately for 25 minutes. Control group participants will be provided some kind of counseling on lifestyle modification, after taking baseline recording. Again the participants will be asked to come to the lab again after 6 weeks and the above mentioned parameters will be recorded again. |