Clinical trial NCT03220945: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2017-07-18
Enrollment: 45
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 weeks after study start
measure: Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)
timeFrame: 15 weeks after study start
measure: Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R)
timeFrame: 15 weeks after study start
measure: Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale
timeFrame: 15 weeks after study start
measure: Change in pain based on brief pain inventory - short form
timeFrame: 15 weeks after study start
Secondary outcomes:
measure: Change in antioxidant status: superoxide dismutase
timeFrame: 15 weeks after study start
measure: Change in antioxidant status: glutathione peroxidase
timeFrame: 15 weeks after study start
measure: Change in serum 8-isoprostane
timeFrame: 15 weeks after study start
measure: Change in saliva cortisol
timeFrame: 15 weeks after study start
measure: Change in hair cortisol
timeFrame: 15 weeks after study start
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
Study officials:
affiliation: Emory University/Winship Cancer Institute
name: Omer Kucuk, MD
role: PRINCIPAL_INVESTIGATOR
References: