N/A
Completed N=68
A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
Source: ClinicalTrials.gov NCT02135653 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Adverse Events — 0; 0 Adverse Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
0; 0 | — |
| SECONDARY Brief Fatigue Inventory Score |
12.2; 27.4 | — |
| SECONDARY Functional Assessment of Cancer Therapy: Physical Well-Being Score |
24.9; 24.3 | — |
| SECONDARY Functional Assessment of Cancer Therapy: Social Well-Being Score |
23.5; 21.4 | — |
| SECONDARY Functional Assessment of Cancer Therapy: Emotional Well-Being Score |
20.1; 21.0 | — |
| SECONDARY Functional Assessment of Cancer Therapy: Functional Well-Being |
22.5; 21.4 | — |
| SECONDARY International Index of Erectile Function Score |
22.5; 21.4 | — |
| SECONDARY International Prostate Symptom Score |
10.8; 15 | — |
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).
Data sourced from ClinicalTrials.gov (NCT02135653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.