Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	July 6, 2011
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