Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

July 23, 2013 updated by: Dr Raghavendra Rao M, Bharath Charitable Cancer Hospital and Institute

Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Health Care Global

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • PMRT
No Intervention: Standard antiemetic care
Standard antiemetic care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months (prior to every cycle of chemotherapy,for 4 cycles)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bharath Charitable Cancer Hospital and Institute

Collaborators

Bangalore Institute of Oncology
CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY

Investigators

  • Principal Investigator: RAGHAVENDRA RAO, PHD, HCG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Y010810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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