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Completed

NCT Number: NCT02620033

Impact of Yoga As Complementary Therapy in Patients Undergoing Radical Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78829, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga therapy

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Dec 2, 2015
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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