Prostate CarcinomaNCT03220945
Comprehensive Yoga Program (SKY) as Adjunct Therapy for Prostate Cancer
A study testing Yoga in people with Prostate Carcinoma, run by Emory University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jan 2016to 27 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Prostate Carcinoma
- Being tested
- Yoga
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Also called Yoga Therapy
Receive yoga instruction
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Control group) | No intervention | Patients may receive yoga instruction for 1 week after post-test 2. |
| Arm II (Yoga group) | Experimental | 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. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 weeks after study start
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.
Measured: 15 weeks after study start
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.
Measured: 15 weeks after study start
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.
Measured: 15 weeks after study start
Change in pain based on brief pain inventory - short form
Pain will be assessed with the brief pain inventory - short form (BPI-SF) questionnaire.
Measured: 15 weeks after study start
Secondary outcomes (5)
Change in antioxidant status: superoxide dismutase
Change in the enzyme indicative of antioxidant status, superoxide dismutase, will be assessed.
Measured: 15 weeks after study start
Change in antioxidant status: glutathione peroxidase
Change in the enzyme indicative of antioxidant status, glutathione peroxidase, will be assessed.
Measured: 15 weeks after study start
Change in serum 8-isoprostane
Serum 8-isoprostane level will also be measured as an indicator of oxidative stress.
Measured: 15 weeks after study start
Change in saliva cortisol
Change in saliva cortisol will be compared before and after the intervention to assess the psychophysiological stress.
Measured: 15 weeks after study start
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.
Measured: 15 weeks after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start6 Jan 2016
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Omer Kucuk, Emory University
- Investigators
- Omer Kucuk, MD, Principal investigator, Emory University/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220945
- Sponsor's protocol ID
- IRB00084607
- Other IDs
- NCI-2016-00025, Winship3059-15, P30CA138292
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2017
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Yoga Program (SKY) as an Adjunct Therapy for Prostate Cancer - A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03220945
- Acronym / sponsor ID
- IRB00084607
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Control group) | No intervention | –Patients may receive yoga instruction for 1 week after post-test 2. |
| Arm II (Yoga group) | Experimental | Other: YogaPatients 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaAlso: Yoga TherapyReceive yoga instruction | Other | Arm II (Yoga group) |
Primary outcome
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.
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.
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.
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.
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.
5 secondary outcomes
Change in antioxidant status: superoxide dismutase
Time frame: 15 weeks after study start
Change in antioxidant status: glutathione peroxidase
Time frame: 15 weeks after study start
Change in serum 8-isoprostane
Time frame: 15 weeks after study start
Change in saliva cortisol
Time frame: 15 weeks after study start
Change in hair cortisol
Time frame: 15 weeks after study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Kucuk, MD principal investigator
Emory University/Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Prostate Carcinoma, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the anxiety and depression, as defined in Hospital Anxiety and Depression Scale (HADS) (time frame: 15 weeks after study start). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.