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

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02135653
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Actual Duration (Months): 81
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Radiotherapy; Other: Eischens Yoga

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: May 24, 2018
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Feasibility Phase: Eischens Yoga Group	Radiation: Radiotherapy; Other: Eischens Yoga
Phase II: Eischens Yoga Group	Radiation: Radiotherapy

Outcome Measures

Primary Outcome Measures

1. Adverse Events [8 weeks]

Secondary Outcome Measures

1. Brief Fatigue Inventory Score [8 weeks]

   A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue

2. Functional Assessment of Cancer Therapy: Physical Well-Being Score [8 weeks]

   7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being

3. Functional Assessment of Cancer Therapy: Social Well-Being Score [8 weeks]

   7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being

4. Functional Assessment of Cancer Therapy: Emotional Well-Being Score [8 weeks]

   6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being

5. Functional Assessment of Cancer Therapy: Functional Well-Being [8 weeks]

   7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being

6. International Index of Erectile Function Score [8 weeks]

   5 item and 5 point Likert-scale The scores range from 0 to 25, with scores >21 indicating normal erectile function and scores <12 indicating moderate to severe ED

7. International Prostate Symptom Score [8 weeks]

   8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Neha Vapiwala, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 24, 2014

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02135653
• Other Study ID Numbers: UPCC 05813
• First Posted: May 12, 2014
• Last Update Posted: May 19, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	Feasibility Phase and Phase II: Radiotherapy and Eischens Yoga have been combined because the feasibility phase's purpose was to identify and recruit patients willing to participate in the Phase II: Radiotherapy and Eischens Yoga. Those in the feasibility are seamlessly enrolled in the Phase II: Radiotherapy and Eischens Yoga.

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy and Eischens Yoga	Radiotherapy without Eischens Yoga
Period Title: Overall Study
STARTED	35	33
COMPLETED	22	28
NOT COMPLETED	13	5

Baseline Characteristics

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga	Total
Arm/Group Description	Radiotherapy and Eischens Yoga	Radiotherapy without Eischens Yoga	Total of all reporting groups
Overall Participants	22	28	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 22.7%	5 17.9%	10 20%
>=65 years	17 77.3%	23 82.1%	40 80%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.1 (6.7)	72.8 (7.0)	72.08 (6.84)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	22 100%	28 100%	50 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	22 100%	28 100%	50 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 9.1%	0 0%	2 4%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	2 7.1%	2 4%
White	19 86.4%	24 85.7%	43 86%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 4.5%	2 7.1%	3 6%
Region of Enrollment (participants) [Number]
United States	22 100%	28 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Adverse Events
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy without Eischens Yoga
Measure Participants	22	28
Number [Adverse Events]	0	0

2. Secondary Outcome

Title	Brief Fatigue Inventory Score
Description	A 9 item 11 point Likert-scale that rapidly assesses fatigue severity 0 - 90 range with greater numbers indicating greater levels of fatigue
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	12.2 (16.3)	27.4 (18.3)

3. Secondary Outcome

Title	Functional Assessment of Cancer Therapy: Physical Well-Being Score
Description	7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better physical well-being
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy Without Eischens Yoga
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	24.9 (2.3)	24.3 (3.0)

4. Secondary Outcome

Title	Functional Assessment of Cancer Therapy: Social Well-Being Score
Description	7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better social well-being
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy without Eischens Yoga
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	23.5 (2.1)	21.4 (3.6)

5. Secondary Outcome

Title	Functional Assessment of Cancer Therapy: Emotional Well-Being Score
Description	6 item 5 point Likert-scale questionnaire. 0 - 30 range with larger number implies better emotional well-being
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy without Eischens Yoga
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	20.1 (3.4)	21.0 (2.2)

6. Secondary Outcome

Title	Functional Assessment of Cancer Therapy: Functional Well-Being
Description	7 item 5 point Likert-scale questionnaire. 0 - 35 range with larger number implies better functional well-being
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy without Eischens Yoga
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	22.5 (4.8)	21.4 (4.0)

7. Secondary Outcome

Title	International Index of Erectile Function Score
Description	5 item and 5 point Likert-scale The scores range from 0 to 25, with scores >21 indicating normal erectile function and scores <12 indicating moderate to severe ED
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy without Eischens Yoga
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	22.5 (4.8)	21.4 (4.0)

8. Secondary Outcome

Title	International Prostate Symptom Score
Description	8 item 6 point Likert-scale Scores on this scale range from 0 to 35, with a score of 8 to 19 indicating moderate urinary symptoms and 20 to 35 severe urinary symptoms
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga
Arm/Group Description	Radiotherapy with Eischens Yoga	Radiotherapy without Eischens Yoga
Measure Participants	22	28
Mean (Standard Deviation) [score on a scale]	10.8 (8.1)	15 (6.4)

Adverse Events

Time Frame	8 Weeks
Adverse Event Reporting Description	Feasibility Phase and Phase II: Yoga Group have been combined because the feasibility phase's purpose was to identify and recruit patients willing to participate in the Phase II: Yoga Group. Those in the feasibility are seamlessly enrolled in the Phase II: Yoga Group.
Arm/Group Title	Feasibility/Phase II: Radiotherapy and Eischens Yoga		Phase II: Radiotherapy Wihtout Eischens Yoga
Arm/Group Description	Radiotherapy and Eischens Yoga		Radiotherapy without Eischens Yoga
All Cause Mortality
	Feasibility/Phase II: Radiotherapy and Eischens Yoga		Phase II: Radiotherapy Wihtout Eischens Yoga
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/28 (0%)
Serious Adverse Events
	Feasibility/Phase II: Radiotherapy and Eischens Yoga		Phase II: Radiotherapy Wihtout Eischens Yoga
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/28 (0%)
Other (Not Including Serious) Adverse Events
	Feasibility/Phase II: Radiotherapy and Eischens Yoga		Phase II: Radiotherapy Wihtout Eischens Yoga
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/28 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.