Prostate CancerNCT02620033
Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy
A study testing Yoga therapy in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The researchers hope to learn if yoga complementary therapy would improve health-related quality of life, recovery of urinary continence and erectile function in patients who underwent prostate cancer surgery (i.e. radical prostatectomy). Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Yoga therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 31 Dec 2021
- 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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men between the age of 30 to 80
- Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
- Is scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
- Has no other active primary malignancy aside from prostate cancer
- Currently not practicing yoga as a form of exercise and/or meditation
- Does not have uncontrolled pain
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- Does not have neurological or musculoskeletal co-morbidity inhibiting exercise
- Has never been diagnosed by health care professionals to have absolute contraindications to exercise testing
- Willing to be randomized to either standard care or intervention group
- Willing to participate in yoga therapy for twelve weeks if randomized to intervention group
- Willing to undergo phlebotomy
- Able and willing to provide informed consent
Who cannot join
- Men under the age of 30 or over the age of 80
- Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
- Is NOT scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
- Has other active primary malignancy aside from prostate cancer
- Currently practicing yoga as a form of exercise and/or meditation
- Has uncontrolled pain
Show all 12Show fewer
- Has neurological or musculoskeletal co-morbidity inhibiting exercise
- Has been diagnosed with psychotic, addictive, and major cognitive disorders
- Has been diagnosed by health care professionals to have absolute contraindications to exercise testing Unwilling to be randomized to either standard care or intervention group
- Unwilling to participate in yoga therapy for twelve weeks if randomized to intervention group
- Unwilling to undergo phlebotomy
- Unable and unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78829
About this study
Official title: Impact of Yoga As Complementary Therapy on Quality of Life, Pro-inflammatory, and Cellular Immune Biomarkers in Patients Undergoing Radical Prostatectomy: A Pilot Randomized-Controlled Trial
The researchers hope to learn if yoga complementary therapy would improve health-related quality of life, recovery of urinary continence and erectile function in patients who underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary therapy would improve health- related quality of life (HRQOL), recovery of urinary continence and erectile function.
This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological markers.
- Conditions
- Prostate Cancer
- Being tested
- Yoga therapy
- Keywords
- Prostatectomy, Yoga therapy, Health related quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga therapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy. |
| Yoga therapy group | Active comparator | Those assigned to the yoga therapy group will be asked to participate in yoga session three times in a week for 6 weeks prior to the scheduled surgery and then re-initiated 3 weeks after the surgery for another 6 weeks. Each session will be approximately 60 - 75 minutes. These yoga session will be held at Nydia's Yoga Therapy Studio, located in San Antonio, TX, under the guidance of certified yoga instructor, Dr. Nydia Tijerina Darby, PT, DPT, MS, who's the owner of the studio and co-investigator of this study. The yoga exercise will be tailored to patient's comfort level. Receives: Behavioral: Yoga therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in health related quality of life measures
health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function.
Measured: One year
Change from baseline in 6-minute walk test
Measured: One year
Total number of participants recruited to and withdraw from the study
Measured: One year
Total number of participants completed the study
Measured: One year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: One year
Secondary outcomes (2)
Change from baseline level on pro-inflammatory biomarkers
Measured: one year
Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start1 Sep 2015
- Primary completion29 Jun 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dharam Kaushik, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620033
- Sponsor's protocol ID
- HSC2015-406H
- Status last verified
- Jan 2022
- First submitted
- 15 Oct 2015
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Kaushik D, Shah PK, Mukherjee N, Ji N, Dursun F, Kumar AP, Thompson IM Jr, Mansour AM, Jha R, Yang X, Wang H, Darby N, Ricardo Rivero J, Svatek RS, Liss MA. Effects of yoga in men with prostate cancer on quality of life and immune response: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2022 Sep;25(3):531-538. doi: 10.1038/s41391-021-00470-w. Epub 2021 Nov 23.
PubMed 34815548
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Yoga As Complementary Therapy on Quality of Life, Pro-inflammatory, and Cellular Immune Biomarkers in Patients Undergoing Radical Prostatectomy: A Pilot Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT02620033
- Acronym / sponsor ID
- HSC2015-406H
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy, Yoga therapy, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Dec 2015 (estimated)
- 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.
The researchers hope to learn if yoga complementary therapy would improve health-related quality of life, recovery of urinary continence and erectile function in patients who underwent prostate cancer surgery (i.e. radical prostatectomy). We hypothesized that in patients undergoing radical prostatectomy, preoperative and postoperative Yoga complementary therapy would improve health- related quality of life (HRQOL), recovery of urinary continence and erectile function.
This two-arm, randomized controlled pilot study will compare Yoga intervention to usual care group. The aim is to evaluate the efficacy of Yoga complementary therapy on HRQOL in patients who underwent radical prostatectomy (RP). Yoga therapy will be given to the intervention group three times in a week for 6 weeks prior to surgery and then initiated 3 weeks after the surgery for another 6 weeks. The yoga exercise will be tailored to the participant's comfort level. As an exploratory analysis, we will evaluate pro-inflammatory and immunological markers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy. |
| Yoga therapy group | Active comparator | Behavioral: Yoga therapyThose assigned to the yoga therapy group will be asked to participate in yoga session three times in a week for 6 weeks prior to the scheduled surgery and then re-initiated 3 weeks after the surgery for another 6 weeks. Each session will be approximately 60 - 75 minutes. These yoga session will be held at Nydia's Yoga Therapy Studio, located in San Antonio, TX, under the guidance of certified yoga instructor, Dr. Nydia Tijerina Darby, PT, DPT, MS, who's the owner of the studio and co-investigator of this study. The yoga exercise will be tailored to patient's comfort level. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Men between the age of 30 to 80
- Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
- Is scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
- Has no other active primary malignancy aside from prostate cancer
- Currently not practicing yoga as a form of exercise and/or meditation
Key exclusion criteria (12 listed)
- Men under the age of 30 or over the age of 80
- Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
- Is NOT scheduled to undergo radical prostatectomy (i.e. robot-assisted or open-approach)
- Has other active primary malignancy aside from prostate cancer
- Currently practicing yoga as a form of exercise and/or meditation
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 |
|---|---|---|
| Yoga therapy | Behavioural | Yoga therapy group |
Primary outcome
Change from baseline in health related quality of life measures
Time frame: One year
health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function.
Change from baseline in 6-minute walk test
Time frame: One year
Total number of participants recruited to and withdraw from the study
Time frame: One year
Total number of participants completed the study
Time frame: One year
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: One year
2 secondary outcomes
Change from baseline level on pro-inflammatory biomarkers
Time frame: one year
Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)
Time frame: One year
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 20 Jan 2022.
- Results publication: PubMed 34815548Kaushik D, Shah PK, Mukherjee N, Ji N, Dursun F, Kumar AP, Thompson IM Jr, Mansour AM, Jha R, Yang X, Wang H, Darby N, Ricardo Rivero J, Svatek RS, Liss MA. Effects of yoga in men with prostate cancer on quality of life and immune response: a pilot randomized controlled trial. Prostate Cancer Prostatic Dis. 2022 Sep;25(3):531-538. doi: 10.1038/s41391-021-00470-w. Epub 2021 Nov 23.
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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.
Dharam Kaushik, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga therapy in people with Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site 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 12 inclusion and 12 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 from baseline in health related quality of life measures (time frame: One year). 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?
On the ClinicalTrials.gov record for NCT02620033, which also lists 1 linked publication.
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 20 Jan 2022.