Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting

Bharath Charitable Cancer Hospital and Institute

Status and phase: Completed; Phase 2

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

Treatments: Behavioral: yoga; Behavioral: Jacobsons PMRT group

Study type: Interventional

Funder types: Other

Identifiers

NCT01387841

Y010810

Details and patient eligibility

About

• 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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Yoga group

Experimental group

Description:

Yoga intervention with standard antiemetic care

Treatment:

Behavioral: yoga

PMRT/Jacobsons Relaxation training

Active Comparator group

Description:

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

Treatment:

Behavioral: Jacobsons PMRT group

Standard antiemetic care

No Intervention group

Description:

Standard antiemetic care only