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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03220945
• Other study ID #: IRB00084607
• Secondary ID: NCI-2016-00025Wi
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 6, 2016
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Other:
• Yoga
Receive yoga instruction

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University/Winship Cancer Institute	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Change in antioxidant status: superoxide dismutase	Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.	15 weeks after study start
Secondary	Change in antioxidant status: glutathione peroxidase	Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.	15 weeks after study start
Secondary	Change in serum 8-isoprostane	Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.	15 weeks after study start
Secondary	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
Secondary	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