Prostate Cancer
Conditions
Keywords
Prostatectomy, Yoga therapy, Health related quality of life
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.
Interventions
BEHAVIORALYoga therapy
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 6-minute walk test | One year | — |
| Total number of participants completed the study | One year | — |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | One year | — |
| Change from baseline in health related quality of life measures | One year | health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function. |
| Total number of participants recruited to and withdraw from the study | One year | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells) | One year |
| Change from baseline level on pro-inflammatory biomarkers | one year |
Countries
United States
Outcome results
None listed