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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-06

Study Completion Date

2023-04-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (Control group)

Patients may receive yoga instruction for 1 week after post-test 2.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Yoga

Intervention Type OTHER

Receive yoga instruction

Interventions

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Yoga

Receive yoga instruction

Intervention Type OTHER

Other Intervention Names

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Yoga Therapy

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No