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NCT Number: NCT03220945

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

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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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

yoga

Other

Receive yoga instruction

Other names: Yoga Therapy

Primary outcomes

  1. Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS)

    Time frame: 15 weeks after study start

    HADS is a 14-item self-rating scale that measures anxiety and depression. HADS will be compared before and after intervention.

  2. Change in global health-status/QOL scale symptoms as defined in the EORTC Quality-of-life Questionnaire (EORTC QLQ-C30)

    Time frame: 15 weeks after study start

    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.

  3. Change in psychological well-being as defined in the Life Orientation Test-Revised (LOT-R)

    Time frame: 15 weeks after study start

    LOT-R is a 10-item self-report scale that measures the expectations about positive outcome in general.

  4. Change in fatigue as defined in 36-item short-form health survey (SF-36) vitality scale

    Time frame: 15 weeks after study start

    SF-36 is a reliable and valid measure of energy/fatigue in the past month.

  5. Change in pain based on brief pain inventory - short form

    Time frame: 15 weeks after study start

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

Secondary outcomes

  1. Change in antioxidant status: superoxide dismutase

    Time frame: 15 weeks after study start

    Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.

  2. Change in antioxidant status: glutathione peroxidase

    Time frame: 15 weeks after study start

    Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.

  3. Change in serum 8-isoprostane

    Time frame: 15 weeks after study start

    Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.

  4. Change in saliva cortisol

    Time frame: 15 weeks after study start

    Change in saliva cortisol will be compared before and after the intervention to assess the psychophysiological stress.

  5. Change in hair cortisol

    Time frame: 15 weeks after study start

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2017
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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