Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620033
• Other study ID #: HSC2015-406H
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Yoga therapy

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 random — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Primary	Change from baseline in 6-minute walk test		One year
Primary	Total number of participants recruited to and withdraw from the study		One year
Primary	Total number of participants completed the study		One year
Primary	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0		One year
Secondary	Change from baseline level on pro-inflammatory biomarkers		one year
Secondary	Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)		One year