Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
This study has been completed.
Sponsor:
Bharath Charitable Cancer Hospital and Institute
Collaborators:
Bangalore Institute of Oncology
CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
Information provided by (Responsible Party):
Dr Raghavendra Rao M, Bharath Charitable Cancer Hospital and Institute
ClinicalTrials.gov Identifier:
NCT01387841
First received: July 1, 2011
Last updated: July 23, 2013
Last verified: July 2013
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Purpose
- 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 | Intervention | 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 |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Nausea and Vomiting
U.S. FDA Resources
Further study details as provided by Bharath Charitable Cancer Hospital and Institute:
Primary Outcome Measures:
- Effect of yoga on chemotherapy induced nausea and vomiting [ Time Frame: 4 months (prior to every cycle of chemotherapy,for 4 cycles) ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- Quality of life after chemotherapy [ Time Frame: 4 months ] [ Designated as safety issue: No ]Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states
| Enrollment: | 120 |
| Study Start Date: | May 2010 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Yoga group
Yoga intervention with standard antiemetic care
|
Behavioral: yoga
Postures,relaxation techniques
|
|
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
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387841
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387841
Locations
| India | |
| Health Care Global | |
| Bangalore, Karnataka, India, 560027 | |
Sponsors and Collaborators
Bharath Charitable Cancer Hospital and Institute
Bangalore Institute of Oncology
CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
Investigators
| Principal Investigator: | RAGHAVENDRA RAO, PHD | HCG |
More Information
| 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 |
| Study First Received: | July 1, 2011 |
| Last Updated: | July 23, 2013 |
| Health Authority: | India: Institutional Review Board India: Indian Council of Medical Research |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 23, 2016