Clinical trial NCT02620033: Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostatectomy
Yoga therapy
Health related quality of life
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-12-02
Enrollment: 30
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change from baseline in health related quality of life measures
timeFrame: One year
measure: Change from baseline in 6-minute walk test
timeFrame: One year
measure: Total number of participants recruited to and withdraw from the study
timeFrame: One year
measure: Total number of participants completed the study
timeFrame: One year
measure: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: One year
Secondary outcomes:
measure: Change from baseline level on pro-inflammatory biomarkers
timeFrame: one year
measure: Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)
timeFrame: One year
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Dharam Kaushik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.