Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
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ClinicalTrials.gov Identifier: NCT01387841 |
Recruitment Status
:
Completed
First Posted
: July 6, 2011
Last Update Posted
: July 24, 2013
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Malignant Female Reproductive System Neoplasm Lymphomas Chemotherapy-induced Nausea and Vomiting | Behavioral: yoga Behavioral: Jacobsons PMRT group | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy |
Study Start Date : | May 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Yoga group
Yoga intervention with standard antiemetic care
|
Behavioral: yoga
Postures,relaxation techniques
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Active Comparator: PMRT/Jacobsons Relaxation training
25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care
|
Behavioral: Jacobsons PMRT group
jacobsons Progressive muscle relaxation training involving 16 muscle groups
Other Name: PMRT
|
No Intervention: Standard antiemetic care
Standard antiemetic care only
|
- Effect of yoga on chemotherapy induced nausea and vomiting [ Time Frame: 4 months (prior to every cycle of chemotherapy,for 4 cycles) ]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
- Quality of life after chemotherapy [ Time Frame: 4 months ]Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387841
India | |
Health Care Global | |
Bangalore, Karnataka, India, 560027 |
Principal Investigator: | RAGHAVENDRA RAO, PHD | HCG |
Responsible Party: | Dr Raghavendra Rao M, Senior Scientist and Head CAM pROGRAM, Bharath Charitable Cancer Hospital and Institute |
ClinicalTrials.gov Identifier: | NCT01387841 History of Changes |
Other Study ID Numbers: |
Y010810 |
First Posted: | July 6, 2011 Key Record Dates |
Last Update Posted: | July 24, 2013 |
Last Verified: | July 2013 |
Keywords provided by Dr Raghavendra Rao M, Bharath Charitable Cancer Hospital and Institute:
yoga chemotherapy nausea vomiting |
Additional relevant MeSH terms:
Nausea Vomiting Genital Neoplasms, Female Signs and Symptoms, Digestive Signs and Symptoms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |