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Completed

NCT Number: NCT02135653

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

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.

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Radiotherapy

Radiation

Eischens Yoga

Other

Primary outcomes

  1. Adverse Events

    Time frame: 8 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
May 12, 2014
Registry last updated
May 19, 2021

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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