Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

NCT ID: NCT01387841

Last Updated: 2013-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-01-31

Brief Summary

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* 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

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Conditions

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Breast Cancer Malignant Female Reproductive System Neoplasm Lymphomas Chemotherapy-induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Yoga group

Yoga intervention with standard antiemetic care

Group Type EXPERIMENTAL

yoga

Intervention Type BEHAVIORAL

Postures,relaxation techniques

PMRT/Jacobsons Relaxation training

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

Group Type ACTIVE_COMPARATOR

Jacobsons PMRT group

Intervention Type BEHAVIORAL

jacobsons Progressive muscle relaxation training involving 16 muscle groups

Standard antiemetic care

Standard antiemetic care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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yoga

Postures,relaxation techniques

Intervention Type BEHAVIORAL

Jacobsons PMRT group

jacobsons Progressive muscle relaxation training involving 16 muscle groups

Intervention Type BEHAVIORAL

Other Intervention Names

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PMRT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bangalore Institute of Oncology

OTHER

Sponsor Role collaborator

CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY

UNKNOWN

Sponsor Role collaborator

Bharath Charitable Cancer Hospital and Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Raghavendra Rao M

Senior Scientist and Head CAM pROGRAM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RAGHAVENDRA RAO, PHD

Role: PRINCIPAL_INVESTIGATOR

HCG

Locations

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Health Care Global

Bangalore, Karnataka, India

Site Status

Countries

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India

Other Identifiers

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Y010810

Identifier Type: -

Identifier Source: org_study_id

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