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Completed

NCT Number: NCT01387841

Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

* 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chemotherapy-induced Nausea and Vomiting Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphomas Lymphoproliferative Disorders Malignant Female Reproductive System Neoplasm Nausea Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Health Care Global

Bangalore, Karnataka, 560027, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

Postures,relaxation techniques

Jacobsons PMRT group

Behavioral

jacobsons Progressive muscle relaxation training involving 16 muscle groups

Other names: PMRT

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Bharath Charitable Cancer Hospital and Institute

Other

Collaborators

  • Bangalore Institute of Oncology
  • CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 6, 2011
Registry last updated
Jul 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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