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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

July 1, 2011
July 6, 2011
July 24, 2013
May 2010
December 2012   (Final data collection date for primary outcome measure)
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
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. progressive muscle relaxation on chemotherapy induced nausea and emesis (CINV) outcomes
Complete list of historical versions of study NCT01387841 on ClinicalTrials.gov Archive Site
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
Quality of life after chemotherapy [ Time Frame: 4 months (after every cycle of chemotherapy) ]
Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states
Not Provided
Not Provided
 
Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Malignant Female Reproductive System Neoplasm
  • Lymphomas
  • Chemotherapy-induced Nausea and Vomiting
  • Behavioral: yoga
    Postures,relaxation techniques
  • Behavioral: Jacobsons PMRT group
    jacobsons Progressive muscle relaxation training involving 16 muscle groups
    Other Name: PMRT
  • Experimental: Yoga group
    Yoga intervention with standard antiemetic care
    Intervention: Behavioral: yoga
  • Active Comparator: PMRT/Jacobsons Relaxation training
    25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care
    Intervention: Behavioral: Jacobsons PMRT group
  • No Intervention: Standard antiemetic care
    Standard antiemetic care only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
Same as current
January 2013
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01387841
Y010810
Yes
Not Provided
Not Provided
Dr Raghavendra Rao M, Bharath Charitable Cancer Hospital and Institute
Bharath Charitable Cancer Hospital and Institute
  • Bangalore Institute of Oncology
  • CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
Principal Investigator: RAGHAVENDRA RAO, PHD HCG
Bharath Charitable Cancer Hospital and Institute
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP