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

Not Applicable

Completed

• Conditions: Prostate Carcinoma
• Interventions: Other: Yoga

• Registration Number: NCT03220945
• Lead Sponsor: Emory University

Brief Summary

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.

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 Timeline

• Study Start: 2016-01-06
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-14
• Study First Posted: 2017-07-18
• Primary Completion: 2023-04-27
• Study Completion: 2023-04-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (Yoga group)	Yoga	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in saliva cortisol	15 weeks after study start	Change in saliva cortisol will be compared before and after the intervention to assess the psychophysiological stress.
Change in serum 8-isoprostane	15 weeks after study start	Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.
Change in antioxidant status: superoxide dismutase	15 weeks after study start	Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.
Change in antioxidant status: glutathione peroxidase	15 weeks after study start	Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.
Change in hair cortisol	15 weeks after study start	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.

Trial Locations

Locations (2)

Emory University/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory Saint Joseph's Hospital; 🇺🇸 Atlanta, Georgia, United States