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

NCT ID: NCT02135653

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Feasibility Phase: Eischens Yoga Group

Radiotherapy

Intervention Type: RADIATION

Eischens Yoga

Intervention Type: OTHER

Phase II: Eischens Yoga Group

Radiotherapy

Intervention Type: RADIATION

Interventions

Radiotherapy

Intervention Type: RADIATION

Eischens Yoga

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neha Vapiwala, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UPCC 05813

Identifier Type: -

Identifier Source: org_study_id