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Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga therapy
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostatectomy, Yoga therapy, Health related quality of life

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Care

Yoga therapy group

Arm Description

Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy.

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.

Outcomes

Primary Outcome Measures

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.
Change from baseline in 6-minute walk test
Total number of participants recruited to and withdraw from the study
Total number of participants completed the study
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Secondary Outcome Measures

Change from baseline level on pro-inflammatory biomarkers
Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)

Full Information

First Posted
October 15, 2015
Last Updated
January 18, 2022
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT02620033
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostatectomy, Yoga therapy, Health related quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy.
Arm Title
Yoga therapy group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga therapy
Primary Outcome Measure Information:
Title
Change from baseline in health related quality of life measures
Description
health related quality of life measures including but not limited to fatigue level, recovery urinary continence, and erectile function.
Time Frame
One year
Title
Change from baseline in 6-minute walk test
Time Frame
One year
Title
Total number of participants recruited to and withdraw from the study
Time Frame
One year
Title
Total number of participants completed the study
Time Frame
One year
Title
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
One year
Secondary Outcome Measure Information:
Title
Change from baseline level on pro-inflammatory biomarkers
Time Frame
one year
Title
Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells)
Time Frame
One year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dharam Kaushik, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78829
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34815548
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.
Results Reference
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Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

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