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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Stage II, III Female breast cancer patients under- going radiotherapy following modified radical mastectomy.
- •Female breast cancer patients in a position to receive yoga therapy.
- •Performance status.
- •ECOG (0,1) grade.
排除标准
- •1.Patients with recurrent malignancies or other co-existing malignancies.
- •Those who had received prior radiation to the chest wall was also excluded from the study.
- •Patients with confounding factors such as diabetes mellitus and hypertension.
- •Patients who were on drugs that modulate the autonomic nervous system.
结局指标
主要结局
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.
时间窗: 2 time points | Initially as soon as the subjects are recruited and | 2nd time assessment will be done after 6 weeks of yoga intervention
2. To assess the effect of yoga on quality of life and psychological functions in female breast cancer patients following post-mastectomy radiotherapy.
时间窗: 2 time points | Initially as soon as the subjects are recruited and | 2nd time assessment will be done after 6 weeks of yoga intervention
次要结局
- To assess the general health of the breast cancer patients following yoga(1 time point)