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

Abramson Cancer Center at Penn Medicine

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: Eischens Yoga

Radiation: Radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT02135653

UPCC 05813

Details and patient eligibility

About

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.

Full 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.

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).