Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

January 18, 2022 updated by: The University of Texas Health Science Center at San Antonio

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78829
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard Care
Those assigned to the standard care group will follow the routine pre- and post-operative care for patients whose undergoing radical prostatectomy.
ACTIVE_COMPARATOR: Yoga therapy group
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.
Behavioral: Yoga therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline level on pro-inflammatory biomarkers
Time Frame: one year
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Dharam Kaushik, MD, University of Texas Health Science Center San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

June 29, 2020

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

October 15, 2015

First Submitted That Met QC Criteria

November 29, 2015

First Posted (ESTIMATE)

December 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 18, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC2015-406H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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