Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy
1 other identifier
interventional
120
1 country
1
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJuly 24, 2013
July 1, 2013
2.6 years
July 1, 2011
July 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Quality of life after chemotherapy
4 months
Study Arms (3)
Yoga group
EXPERIMENTALYoga intervention with standard antiemetic care
PMRT/Jacobsons Relaxation training
ACTIVE COMPARATOR25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care
Standard antiemetic care
NO INTERVENTIONStandard antiemetic care only
Interventions
jacobsons Progressive muscle relaxation training involving 16 muscle groups
Eligibility Criteria
You may qualify if:
- Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
- Age between 30-70 years.
- Chemotherapy naïve.
- High school education.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Health Care Global
Bangalore, Karnataka, 560027, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
RAGHAVENDRA RAO, PHD
HCG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist and Head CAM pROGRAM
Study Record Dates
First Submitted
July 1, 2011
First Posted
July 6, 2011
Study Start
May 1, 2010
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
July 24, 2013
Record last verified: 2013-07