Malur R Usharani, PKL Nandini, Raghavendra Rao M, Mahesh Kavya, S Aishvarrya, Shekhar G Patil, Diwakar B Ravi, H P Shashidhara, C T Satheesh, Naik Radheshyam, Basavalinga S Ajaikumar, Gopinath KS and Ramesh BS
Objective: Nausea and emesis are two major side effects and known to be partly psychological rather than purely pharmacological in nature. Yoga as a complimentary modality is extensively known to reduce anxiety, physiological arousal and stress associated with chemotherapy. This study will compare the effect of Yoga with Jacobson's relaxation to understand the underlying neural mechanisms like gastric motility changes (Electrogastrogram) and sympathovagal changes on HRV spectral analysis that accompany chemotherapy induced nausea and emesis and evaluate the influence of intervention on these mechanisms.
Method/Design: This is a randomized controlled 3 arm clinical Trial. 120 chemo naive subjects will be randomized into three groups, with 42 subjects for Yoga, 42 for Jacobson's group and 36 in control group.
Setting: This study will be conducted at Comprehensive cancer care hospital.
Participants: 200 patients will be screened and 150 subjects who satisfy the selection criteria (those with gynecological malignancies, between 18-70 years, with basic education and those who have never been exposed to chemotherapy before and who give their consent to participate and give consent to participate) will be taken into the study.
Primary outcome measure: The Functional Living Index-Emesis (FLIE), emesis-and nausea-specific Qol questionnaire is administered with a 24 hour recall followed by a 4-day recall for studying acute and delayed chemotherapy-induced emesis.
Secondary outcome measure: Include psychological measures such anxiety, depression and perceived stress that influence chemotherapy induced nausea and emesis. It also includes cardiac autonomic function and surface electrogastrogram to assess the neurophysiological correlates of yoga in modulating nausea and emesis.
Intervention: The yoga intervention consists of asanas (postures), breathing exercises, and relaxation techniques for 25 minutes. The progressive muscle relaxation involves tightening each and every muscle of the body and then relaxing the same one by one for 25 minutes.
Conclusion: This study will help us understand the mechanism of action of yoga intervention in controlling chemotherapy induced nausea and vomiting.
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Journal of Integrative Oncology received 495 citations as per Google Scholar report
