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Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

This study is currently recruiting participants.
Verified December 2011 by Bharath Charitable Cancer Hospital and Institute
Sponsor:
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: December 7, 2011
Last verified: December 2011
History of Changes
  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:

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


Estimated Enrollment: 120
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (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
Other Name: Yoga
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01387841

Contacts
Contact: Usha Rani, BAMS, MSc 40206000 ext 6309 ushaaayur@yahoo.com

Locations
India
Health Care Global Recruiting
Bangalore, Karnataka, India, 560027
Principal Investigator: RAGHAVENDRA RAO, BNYS,PHD            
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

No publications provided

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: December 7, 2011
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:
Breast Neoplasms
Neoplasms
Genital Neoplasms, Female
Lymphoma
Nausea
Vomiting
Neoplasms by Site
Breast Diseases
Skin Diseases
Urogenital Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013