Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Phase 2

Completed

• Conditions: Breast Cancer; Malignant Female Reproductive System Neoplasm; Lymphomas; Chemotherapy-induced Nausea and Vomiting
• Interventions: Behavioral: yoga; Behavioral: Jacobsons PMRT group

• Registration Number: NCT01387841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-07-01
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Primary Completion: 2012-12
• Study Completion: 2013-01
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-23
• Last Update Posted: 2013-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga group	yoga	Yoga intervention with standard antiemetic care
PMRT/Jacobsons Relaxation training	Jacobsons PMRT group	25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Health Care Global; 🇮🇳 Bangalore, Karnataka, India