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Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02620033
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Yoga therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : September 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

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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



Primary Outcome Measures :
  1. 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.

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

Secondary Outcome Measures :
  1. Change from baseline level on pro-inflammatory biomarkers [ Time Frame: one year ]
  2. Change from baseline level on cellular immune response (i.e. measuring the Natural Killer Cell and regulatory-T cells) [ Time Frame: One year ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02620033


Locations
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United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78829
Contact: Grace Ihsiu Todd, MSN, ANP-BC    210-550-0715    toddg@uthscsa.edu   
Contact: Dharam Kaushik, MD    210-567-5676    kaushik@uthscsa.edu   
Principal Investigator: Dharam Kaushik, MD         
Sub-Investigator: Nydia Tijerina Darby, PT, DPT, MS         
Sub-Investigator: Stacey Young-McCaughan, RN, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio

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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02620033     History of Changes
Other Study ID Numbers: HSC2015-406H
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Keywords provided by The University of Texas Health Science Center at San Antonio:
Prostatectomy
Yoga therapy
Health related quality of life