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A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02135653
Recruitment Status : Completed
First Posted : May 12, 2014
Results First Posted : May 19, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.

Condition or disease Intervention/treatment
Prostate Cancer Radiation: Radiotherapy Other: Eischens Yoga

Detailed Description:
The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
Actual Study Start Date : March 2013
Actual Primary Completion Date : May 24, 2018
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Feasibility Phase: Eischens Yoga Group Radiation: Radiotherapy
Other: Eischens Yoga
Phase II: Eischens Yoga Group Radiation: Radiotherapy



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Brief Fatigue Inventory Score [ Time Frame: 8 weeks ]
    A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue

  2. Functional Assessment of Cancer Therapy: Physical Well-Being Score [ Time Frame: 8 weeks ]
    7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being

  3. Functional Assessment of Cancer Therapy: Social Well-Being Score [ Time Frame: 8 weeks ]
    7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being

  4. Functional Assessment of Cancer Therapy: Emotional Well-Being Score [ Time Frame: 8 weeks ]
    6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being

  5. Functional Assessment of Cancer Therapy: Functional Well-Being [ Time Frame: 8 weeks ]
    7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being

  6. International Index of Erectile Function Score [ Time Frame: 8 weeks ]
    5 item and 5 point Likert-scale The scores range from 0 to 25, with scores >21 indicating normal erectile function and scores <12 indicating moderate to severe ED

  7. International Prostate Symptom Score [ Time Frame: 8 weeks ]
    8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults with stage I or II prostate cancer undergoing radiation therapy. Enrolled subjects will not have smoked nor taken any regular yoga classes in the 6 months preceding their participation in the study.

Additionally they will have not undergone a surgical prostatectomy

Criteria

Inclusion Criteria:

Patients

  • Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted.
  • Patients of age >18 years, and all races will be included in the study.
  • Patients must have an ECOG Performance Score ≤ 1
  • All patients must sign an informed consent form

Caregivers

  • Subject is age >18 years
  • Subject is English-speaking
  • Subject must sign an informed consent form

Exclusion Criteria

Patients

  • Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score.
  • Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
  • Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
  • Patients who are undergoing chemotherapy for any reason
  • Patients with evidence of metastatic disease

Caregivers

  • Subjects that are unwilling or unable to provide informed consent
  • Subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions
  • Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
  • Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).

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): NCT02135653


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Neha Vapiwala, MD Abramson Cancer Center of the University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Abramson Cancer Center of the University of Pennsylvania:
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02135653    
Other Study ID Numbers: UPCC 05813
First Posted: May 12, 2014    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: May 19, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases