Comprehensive Yoga Program (SKY) as Adjunct Therapy for Prostate Cancer

A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study

This randomized pilot trial studies the effect of comprehensive yoga program (SKY) in reducing stress, pain, and fatigue, and improving psychological well-being in patients with prostate cancer. SKY is one of the most widely used breathing techniques derived from yoga. SKY Yoga may improve quality of life in patients with prostate cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Other: Yoga

Detailed Description

PRIMARY OBJECTIVES:

I. Determine any change in pain, fatigue and psychological well-being as a result of SKY in prostate cancer (PCa) patients.

II. Assess changes in some physiological parameters in response to SKY in the same subjects, compare these with those from Part 1, and assess whether these translate into clinical effects.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (Control Group): Patients undergo collection of blood, saliva, and hair samples after signing consent (pre-test 1), within 6-8 weeks after pre-test 1 (post-test 1), and within 2-4 months after post-test 1 (post-test 2). Patients may receive yoga instruction for 1 week after post-test 2.

ARM II (Yoga Group): Patients receive yoga instruction over approximately 3 hours daily for 5 days of week 1 and over 2 hours once a week of weeks 2-13. Patients also undergo collection of blood, saliva, and hair samples within 2 months prior to starting yoga instruction, within weeks 2-3, and within weeks 14-15.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory Saint Joseph's Hospital
    • Atlanta, Georgia, United States, 30322
      • Emory University/Winship Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Having finished radiotherapy at least two months ago
• Ability to speak and read English and give informed consent
• Have an interest in being part of a study to evaluate yoga-derived exercises and eager to practice some kind of relaxation exercise daily for 3 months

Exclusion Criteria:

• Have a diagnosis of psychiatric illness or other major illness in addition to PCa, such as other cancers, uncontrolled hypertension, lung disease, liver disease or heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm I (Control group); Patients may receive yoga instruction for 1 week after post-test 2.
Experimental: Arm II (Yoga group); Patients receive yoga instruction over approximately 3 hours daily for 5 days of week 1 and over 2 hours once a week of weeks 2-13.	Other: Yoga; Receive yoga instruction; Other Names: Yoga Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS)	HADS is a 14-item self-rating scale that measures anxiety and depression. HADS will be compared before and after intervention.	15 weeks after study start
Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)	European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30) is a cancer-specific 30-item questionnaire incorporating 5-functioning scales, a global health-status/QOL scale and symptoms assessment.	15 weeks after study start
Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R)	LOT-R is a 10-item self-report scale that measures the expectations about positive outcome in general.	15 weeks after study start
Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale	SF-36 is a reliable and valid measure of energy/fatigue in the past month.	15 weeks after study start
Change in pain based on brief pain inventory - short form	Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire.	15 weeks after study start

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in antioxidant status: superoxide dismutase	Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.	15 weeks after study start
Change in antioxidant status: glutathione peroxidase	Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.	15 weeks after study start
Change in serum 8-isoprostane	Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.	15 weeks after study start
Change in saliva cortisol	Change in saliva cortisol will be compared before and after the intervention to assess the psychophysiological stress.	15 weeks after study start
Change in hair cortisol	Change in hair cortisol will be assessed as a measure of psychophysiological stress using a 1-inch strand of hair taken from the back of the head.	15 weeks after study start

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Omer Kucuk, MD, Emory University/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2025

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 14, 2017
• First Posted (Actual): July 18, 2017

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRB00084607; P30CA138292 (U.S. NIH Grant/Contract); NCI-2016-00025 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); Winship3059-15 (Other Identifier: Emory University/Winship Cancer Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No