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 Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- JIPMER
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- 1.To study the Pulmonary and Cardiovascular function test parameters.
Study Overview
Brief Summary
Primary purpose of the protocol
Breast 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. Yogahelps 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?
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female breast cancer patients who have undergone modified radical mastectomy and planned for radiation to the axilla and supraclavicular lymphnodes.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1.To study the Pulmonary and Cardiovascular function test parameters.
Time Frame: 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.
2.To study the levels of Metabolic markers.
Time Frame: 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.
3.To study the Psychological stress score.
Time Frame: 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.
4.To asses the effect of Yoga on the above parameters and compare them with the control group.
Time Frame: 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.
Secondary Outcomes
- 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)