| CTRI Number |
CTRI/2015/01/005404 [Registered on: 14/01/2015] Trial Registered Retrospectively |
| Last Modified On: |
08/01/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on lung,heart functions and stress score in breast cancer patients undergoing radiotherapy. |
|
Scientific Title of Study
|
Effect of yoga on pulmonary,cardiovascular and metabolic functions and stress score in post- mastectomy breast cancer patients undergoing radiotherapy:a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devi R Nithiya |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Physiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9994313991 |
| Fax |
|
| Email |
nithiya.ravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravati Pal |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of Physiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09360682406 |
| Fax |
|
| Email |
drpravatipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devi R Nithiya |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Physiology
JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9994313991 |
| Fax |
|
| Email |
nithiya.ravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| intramural funds provided by the (institution) JIPMER |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER
PONDICHERRY |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devi R Nithiya |
JIPMER |
Dept. of Physiology,
first floor,
academic center block, JIPMER
PONDICHERRY
Pondicherry
PONDICHERRY |
9994313991
nithiya.ravi@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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
post mastectomy patients receiving radiotherapy on OPD basis. general conditions of the patients is fair, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
radiotherapy |
the patients in the control group will undergo only radiotherapy without yoga intervention |
| Intervention |
yoga intervention during radiotherapy |
yoga module for cancer patients approved by MDNIY. the patients in yoga group will undergo yoga therapy for 20 mins daily for 5 days a week for 6 weeks under supervision when they come for radiotherapy. and continue yoga for 3 months at home |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female breast cancer patients who have undergone modified radical mastectomy and planned for radiation to the axilla and supraclavicular lymphnodes
|
|
| ExclusionCriteria |
| Details |
-Patients with pre-existing lung disease.
-Patients not willing to perform yoga.
-Patients with extreme mobility problems
-Patients who already perform yoga in pre-treatment phase.
-Patients with recurrent malignancy.
-Patients with prior radiation to chest wall.
-Patients with diabetes or Hypertension
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the Pulmonary and Cardiovascular function test parameters.
2.To study the levels of Metabolic markers.
3.To study the Psychological stress score.
4.To asses the effect of Yoga on the above parameters and compare them with the control group.
|
all parameters will be assessed thrice for each participant during the study. Baseline values will be obtained at the beginning of RT, the second reading will be obtained at the end of 6 weeks of RT and the final reading will be obtained at the end of 3 months of completion of RT. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the psychological stress in breast cancer patients undergoing radiotherapy and compare with the yoga group |
preRT, at the end of RT and 3 months after RT |
|
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Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/05/2014 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Primary purpose of the protocolBreast cancer is one of the most common cancers in India. Post-op radiotherapy (RT) has shown to reduce the recurrence rate of breast cancer in treated patients. However, radiation to the chest wall has been implicated in the risk of developing pulmonary and cardiovascular complications. Breast cancer patients develop psychological stress due to their diagnosis of cancer per-se and also while undergoing various treatment modalities like surgery, chemotherapy and radiotherapy. Stress contributes to the disturbance in autonomic balance in the body. Heart rate variability (HRV) is an useful measure of autonomic functions and finapres parameters measures the cardiovascular functions at rest.RT is also known to cause oxidative stress and reduce the antioxidant levels in the body. Chronic inflammation is believed to contribute to the development and progression of breast cancer. Yoga helps in improving the pulmonary functions. It helps the body to effectively counteract the oxidative stress by increasing the antioxidant levels. Yoga contributes to the physical, psychological and spiritual well-being of an individual. Study hypothesisCan Yoga improve the Pulmonary & Cardiovascular functions, levels of Antioxidants & Inflammatory markers and Psychological Stress in breast cancer patients undergoing Post-total mastectomy Radiotherapy?
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