Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Study Overview
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Brief Summary
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This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients. This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.

Official Title
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Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy

Conditions
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Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas, Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
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* Behavioral: yoga
* Behavioral: Jacobsons PMRT group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with gynecologic malignancies (breast, ovary) and Lymphomas. Age between 30-70 years. Chemotherapy naïve. High school education. Exclusion Criteria: Those with brain metastases Concurring medical condition likely to influence survival Uncontrolled diabetes and hypertension GI metastases, peritoneal fluid, uraemia Neurological disorders such as Parkinson's disease, myotonic dystrophy etc. GI obstruction and past H/o abdominal surgeries. Cognitive impairments. Regular participation in a behavioral intervention/yoga in the last six months

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga group<br>Yoga intervention with standard antiemetic care | Behavioral: yoga<br>* Postures,relaxation techniques<br>|
| Active Comparator: PMRT/Jacobsons Relaxation training<br>25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care | Behavioral: Jacobsons PMRT group<br>* jacobsons Progressive muscle relaxation training involving 16 muscle groups<br>* Other names: PMRT;|
| No Intervention: Standard antiemetic care<br>Standard antiemetic care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of yoga on chemotherapy induced nausea and vomiting | This study is to evaluate the effects of yoga intervention vs. Jacobsons progressive muscle relaxation vs. standard of care only on chemotherapy induced nausea and emesis (CINV) outcomes | 4 months (prior to every cycle of chemotherapy,for 4 cycles) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life after chemotherapy | Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, yoga, chemotherapy, vomiting