An interventional study of Yoga in Prostate Carcinoma, sponsored by Emory University. Completed at 2 sites in United States. Open to male participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
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.
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's enrollment of 45 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.
Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.
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Exclusion Criteria:
Patients may receive yoga instruction for 1 week after post-test 2.
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
Also known as: Yoga Therapy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 15 weeks after study start
Change in antioxidant status: superoxide dismutase
Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.
Time frame: 15 weeks after study start
Change in antioxidant status: glutathione peroxidase
Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.
Time frame: 15 weeks after study start
Change in serum 8-isoprostane
Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.
Time frame: 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.
Time frame: 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.
Time frame: 15 weeks after study start
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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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