Clinical trial NCT02135653: A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
Official title: A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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).

Primary outcomes:
measure: Adverse Events
timeFrame: 8 weeks
Secondary outcomes:
measure: Brief Fatigue Inventory Score
timeFrame: 8 weeks
measure: Functional Assessment of Cancer Therapy: Physical Well-Being Score
timeFrame: 8 weeks
measure: Functional Assessment of Cancer Therapy: Social Well-Being Score
timeFrame: 8 weeks
measure: Functional Assessment of Cancer Therapy: Emotional Well-Being Score
timeFrame: 8 weeks
measure: Functional Assessment of Cancer Therapy: Functional Well-Being
timeFrame: 8 weeks
measure: International Index of Erectile Function Score
timeFrame: 8 weeks
measure: International Prostate Symptom Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Neha Vapiwala, MD
role: PRINCIPAL_INVESTIGATOR
References: