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Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

This study has been completed.
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: July 23, 2013
Last verified: July 2013
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

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: 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:
Breast Neoplasms
Genital Neoplasms, Female
Nausea
Vomiting
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Signs and Symptoms, Digestive
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014