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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
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

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 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
Primary Completion Date : December 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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



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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

Information from the National Library of Medicine

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


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

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