Trial Outcomes & Findings for A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer (NCT NCT02135653)

NCT ID: NCT02135653

Last Updated: 2021-05-19

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 68 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-05-19

Participant Flow

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.

Participant milestones

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga Radiotherapy without Eischens Yoga
Overall Study STARTED	35	33
Overall Study COMPLETED	22	28
Overall Study NOT COMPLETED	13	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy and Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	23 Participants n=7 Participants	40 Participants n=5 Participants
Age, Continuous	71.1 years STANDARD_DEVIATION 6.7 • n=5 Participants	72.8 years STANDARD_DEVIATION 7.0 • n=7 Participants	72.08 years STANDARD_DEVIATION 6.84 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	28 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
Adverse Events	0 Adverse Events	0 Adverse Events

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
Brief Fatigue Inventory Score	12.2 score on a scale Standard Deviation 16.3	27.4 score on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
Functional Assessment of Cancer Therapy: Physical Well-Being Score	24.9 score on a scale Standard Deviation 2.3	24.3 score on a scale Standard Deviation 3.0

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
Functional Assessment of Cancer Therapy: Social Well-Being Score	23.5 score on a scale Standard Deviation 2.1	21.4 score on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
Functional Assessment of Cancer Therapy: Emotional Well-Being Score	20.1 score on a scale Standard Deviation 3.4	21.0 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
Functional Assessment of Cancer Therapy: Functional Well-Being	22.5 score on a scale Standard Deviation 4.8	21.4 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
International Index of Erectile Function Score	22.5 score on a scale Standard Deviation 4.8	21.4 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Feasibility/Phase II: Radiotherapy and Eischens Yoga n=22 Participants Radiotherapy with Eischens Yoga	Phase II: Radiotherapy Without Eischens Yoga n=28 Participants Radiotherapy without Eischens Yoga
International Prostate Symptom Score	10.8 score on a scale Standard Deviation 8.1	15 score on a scale Standard Deviation 6.4

Adverse Events

Feasibility/Phase II: Radiotherapy and Eischens Yoga

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase II: Radiotherapy Wihtout Eischens Yoga

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Neha Vapiwala

University of Pennsylvania

Phone: (215) 662-2337

Email: Neha.Vapiwala@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place