search
Back to results

Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Primary Purpose

Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
yoga
Jacobsons PMRT group
Sponsored by
Bharath Charitable Cancer Hospital and Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring yoga, chemotherapy, nausea, vomiting

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health Care Global

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Yoga group

PMRT/Jacobsons Relaxation training

Standard antiemetic care

Arm Description

Yoga intervention with standard antiemetic care

25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care

Standard antiemetic care only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 1, 2011
Last Updated
July 23, 2013
Sponsor
Bharath Charitable Cancer Hospital and Institute
Collaborators
Bangalore Institute of Oncology, CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
search

1. Study Identification

Unique Protocol Identification Number
NCT01387841
Brief Title
Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
Official Title
Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bharath Charitable Cancer Hospital and Institute
Collaborators
Bangalore Institute of Oncology, CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Malignant Female Reproductive System Neoplasm, Lymphomas, Chemotherapy-induced Nausea and Vomiting
Keywords
yoga, chemotherapy, nausea, vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Experimental
Arm Description
Yoga intervention with standard antiemetic care
Arm Title
PMRT/Jacobsons Relaxation training
Arm Type
Active Comparator
Arm Description
25 minutes of progressive muscle relaxation training will be given to this group with standard antiemetic care
Arm Title
Standard antiemetic care
Arm Type
No Intervention
Arm Description
Standard antiemetic care only
Intervention Type
Behavioral
Intervention Name(s)
yoga
Intervention Description
Postures,relaxation techniques
Intervention Type
Behavioral
Intervention Name(s)
Jacobsons PMRT group
Other Intervention Name(s)
PMRT
Intervention Description
jacobsons Progressive muscle relaxation training involving 16 muscle groups
Primary Outcome Measure Information:
Title
Effect of yoga on chemotherapy induced nausea and vomiting
Description
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
Time Frame
4 months (prior to every cycle of chemotherapy,for 4 cycles)
Secondary Outcome Measure Information:
Title
Quality of life after chemotherapy
Description
Here we evaluate the effects of yoga intervention on secondary outcomes such as quality of life and anxiety states
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RAGHAVENDRA RAO, PHD
Organizational Affiliation
HCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Care Global
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India

12. IPD Sharing Statement

Learn more about this trial

Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

We'll reach out to this number within 24 hrs