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

NCT02135653 | Completed Results DMC

• 1 other identifier: UPCC 05813
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  8 weeks

Secondary Outcomes (7)

• Brief Fatigue Inventory Score

  8 weeks

• Functional Assessment of Cancer Therapy: Physical Well-Being Score

  8 weeks

• Functional Assessment of Cancer Therapy: Social Well-Being Score

  8 weeks

• Functional Assessment of Cancer Therapy: Emotional Well-Being Score

  8 weeks

• Functional Assessment of Cancer Therapy: Functional Well-Being

  8 weeks

Study Arms (2)

Feasibility Phase: Eischens Yoga Group

Radiation: Radiotherapy; Other: Eischens Yoga

Phase II: Eischens Yoga Group

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

Feasibility Phase: Eischens Yoga Group; Phase II: Eischens Yoga Group

Eischens Yoga OTHER

Feasibility Phase: Eischens Yoga Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Dr. Neha Vapiwala
• Organization: University of Pennsylvania

Neha.Vapiwala@pennmedicine.upenn.edu

(215) 662-2337

Study Officials

• Neha Vapiwala, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 12, 2014
• Study Start: March 1, 2013
• Primary Completion: May 24, 2018
• Study Completion: December 1, 2019
• Last Updated: May 19, 2021
• Results First Posted: May 19, 2021

Record last verified: 2021-04

Locations

US (1)