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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02135653
• Other study ID #: UPCC 05813
• Status: Completed
• Start date: March 2013
• Est. completion date: December 2019

Study information

• Verified date: April 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2019
• Est. primary completion date: May 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiotherapy

Other:
• Eischens Yoga

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events		8 weeks
Secondary	Brief Fatigue Inventory Score	A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue	8 weeks
Secondary	Functional Assessment of Cancer Therapy: Physical Well-Being Score	7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being	8 weeks
Secondary	Functional Assessment of Cancer Therapy: Social Well-Being Score	7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being	8 weeks
Secondary	Functional Assessment of Cancer Therapy: Emotional Well-Being Score	6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being	8 weeks
Secondary	Functional Assessment of Cancer Therapy: Functional Well-Being	7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being	8 weeks
Secondary	International Index of Erectile Function Score	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	8 weeks
Secondary	International Prostate Symptom Score	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	8 weeks