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Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Sponsor
Bharath Charitable Cancer Hospital and Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01387841
Collaborator
Bangalore Institute of Oncology (Other), CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY (Other)
120
Enrollment
1
Location
3
Arms
32.1
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: yoga
  • Behavioral: Jacobsons PMRT group
 Phase 2

Study Design

Study Type:
Interventional
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 1, 2010
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Effect of yoga on chemotherapy induced nausea and vomiting [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 [4 months]

      Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Raghavendra Rao M, Senior Scientist and Head CAM pROGRAM, Bharath Charitable Cancer Hospital and Institute
    ClinicalTrials.gov Identifier:
    NCT01387841
    Other Study ID Numbers:
    • Y010810
    First Posted:
    Jul 6, 2011
    Last Update Posted:
    Jul 24, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by Dr Raghavendra Rao M, Senior Scientist and Head CAM pROGRAM, Bharath Charitable Cancer Hospital and Institute
    yoga
    chemotherapy
    nausea
    vomiting
    Additional relevant MeSH terms:
    Genital Neoplasms, Female
    Nausea
    Vomiting

    Study Results

    No Results Posted as of Jul 24, 2013