Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387841
• Other study ID #: Y010810
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2011
• Last updated: July 23, 2013
• Start date: May 2010
• Est. completion date: January 2013

Study information

• Verified date: July 2013
• Source: Bharath Charitable Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review BoardIndia: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Chemotherapy-induced Nausea and Vomiting
• Genital Neoplasms, Female
• Lymphomas
• Malignant Female Reproductive System Neoplasm
• Nausea
• Vomiting

Intervention

Behavioral:
• yoga
Postures,relaxation techniques
• Jacobsons PMRT group
jacobsons Progressive muscle relaxation training involving 16 muscle groups

Locations

Country	Name	City	State
India	Health Care Global	Bangalore	Karnataka

Sponsors (3)

Lead Sponsor	Collaborator
Bharath Charitable Cancer Hospital and Institute	Bangalore Institute of Oncology, CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of yoga on chemotherapy induced nausea and vomiting	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)	No
Secondary	Quality of life after chemotherapy	Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states	4 months	No