NCT02620033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

4.8 years

First QC Date

October 15, 2015

Last Update Submit

January 18, 2022

Conditions

Prostate Cancer

Keywords

ProstatectomyYoga therapyHealth related quality of life

Outcome Measures

Primary Outcomes (5)

  • 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

  • Change from baseline in 6-minute walk test

    One year

  • Total number of participants recruited to and withdraw from the study

    One year

  • Total number of participants completed the study

    One year

  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

    One year

Secondary Outcomes (2)

  • Change from baseline level on pro-inflammatory biomarkers

    one year

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

    One year

Study Arms (2)

Standard Care

NO INTERVENTION

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

Yoga therapy group

ACTIVE COMPARATOR

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

Interventions

Yoga therapyBEHAVIORAL
Yoga therapy group

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78829, United States

Location

Related 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 randomized controlled trial. Prostate Cancer Prostatic Dis. 2022 Sep;25(3):531-538. doi: 10.1038/s41391-021-00470-w. Epub 2021 Nov 23.

    PMID: 34815548RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Yoga

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Dharam Kaushik, MD

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

December 2, 2015

Study Start

September 1, 2015

Primary Completion

June 29, 2020

Study Completion

December 31, 2021

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

US(1)