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

Primary Purpose

Prostate Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Carcinoma

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Emory University/Winship Cancer Institute
  • Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Arm I (Control group)

Arm II (Yoga group)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
Change in pain based on brief pain inventory - short form
Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire.

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2017
Last Updated
May 2, 2023
Sponsor
Emory University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03220945
Brief Title
Comprehensive Yoga Program (SKY) as Adjunct Therapy for Prostate Cancer
Official Title
A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 6, 2016 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Control group)
Arm Type
No Intervention
Arm Description
Patients may receive yoga instruction for 1 week after post-test 2.
Arm Title
Arm II (Yoga group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Yoga
Other Intervention Name(s)
Yoga Therapy
Intervention Description
Receive yoga instruction
Primary Outcome Measure Information:
Title
Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS)
Description
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
Title
Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)
Description
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
Title
Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R)
Description
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
Title
Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale
Description
SF-36 is a reliable and valid measure of energy/fatigue in the past month.
Time Frame
15 weeks after study start
Title
Change in pain based on brief pain inventory - short form
Description
Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire.
Time Frame
15 weeks after study start
Secondary Outcome Measure Information:
Title
Change in antioxidant status: superoxide dismutase
Description
Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.
Time Frame
15 weeks after study start
Title
Change in antioxidant status: glutathione peroxidase
Description
Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.
Time Frame
15 weeks after study start
Title
Change in serum 8-isoprostane
Description
Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.
Time Frame
15 weeks after study start
Title
Change in saliva cortisol
Description
Change in saliva cortisol will be compared before and after the intervention to assess the psychophysiological stress.
Time Frame
15 weeks after study start
Title
Change in hair cortisol
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Kucuk, MD
Organizational Affiliation
Emory University/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

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

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