Trial Outcomes & Findings for A Supervised Prehabilitation Program for Patients With Pancreatic Cancer (NCT NCT05692323)
NCT ID: NCT05692323
Last Updated: 2026-04-15
Results Overview
PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions. PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
From Baseline to 3 Months
Results posted on
2026-04-15
Participant Flow
The trial opened to accrual on 4/12/2023 with first subject enrolled on study 5/15/2023. A total of 16 patients consented; 0 subjects failed screening; 16 subjects went on treatment, 16 completed study intervention, and 16 were deemed evaluable. The last subject went off treatment on 10/15/2025. Last data collection for primary endpoint confirmed on 10/15/2025 as the primary completion date. All 16 subjects are off study.
Participant milestones
| Measure |
Supervised Prehabilitation Exercise Program
PREHAB: 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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|---|---|
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Overall Study
STARTED
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16
|
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Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Supervised Prehabilitation Program for Patients With Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Supervised Prehabilitation Exercise Program
n=16 Participants
PREHAB: 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=193 Participants
|
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Age, Categorical
>=65 years
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11 Participants
n=193 Participants
|
|
Age, Continuous
|
70.5 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=193 Participants
|
PRIMARY outcome
Timeframe: From Baseline to 3 MonthsPREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions. PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions
Outcome measures
| Measure |
Supervised Prehabilitation Exercise Program
n=16 Participants
PREHAB: 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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|---|---|
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PREHAB Feasibility
|
10 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 3 MonthsPREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO). PREHAB Program Safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.
Outcome measures
| Measure |
Supervised Prehabilitation Exercise Program
n=16 Participants
PREHAB: 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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|---|---|
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PREHAB Program Safety
Abdominal pain
|
2 Participants
|
|
PREHAB Program Safety
Alanine aminotransferase increased
|
1 Participants
|
|
PREHAB Program Safety
Alkaline phosphatase increased
|
2 Participants
|
|
PREHAB Program Safety
Anemia
|
2 Participants
|
|
PREHAB Program Safety
Aspartate aminotransferase increased
|
1 Participants
|
|
PREHAB Program Safety
Back pain
|
1 Participants
|
|
PREHAB Program Safety
Blood bilirubin increased
|
1 Participants
|
|
PREHAB Program Safety
Confusion
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1 Participants
|
|
PREHAB Program Safety
Constipation
|
1 Participants
|
|
PREHAB Program Safety
Diarrhea
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2 Participants
|
|
PREHAB Program Safety
Dizziness
|
1 Participants
|
|
PREHAB Program Safety
Dyspnea
|
1 Participants
|
|
PREHAB Program Safety
Fatigue
|
6 Participants
|
|
PREHAB Program Safety
Fever
|
1 Participants
|
|
PREHAB Program Safety
Headache
|
1 Participants
|
|
PREHAB Program Safety
Hyperglycemia
|
1 Participants
|
|
PREHAB Program Safety
Hypocalcemia
|
1 Participants
|
|
PREHAB Program Safety
Hypokalemia
|
1 Participants
|
|
PREHAB Program Safety
Hyponatremia
|
1 Participants
|
|
PREHAB Program Safety
Hypotension
|
1 Participants
|
|
PREHAB Program Safety
Nausea
|
3 Participants
|
|
PREHAB Program Safety
Platelet Count Decreased
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1 Participants
|
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PREHAB Program Safety
Sepsis
|
1 Participants
|
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PREHAB Program Safety
Vertigo
|
1 Participants
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Adverse Events
Supervised Prehabilitation Exercise Program
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Supervised Prehabilitation Exercise Program
n=16 participants at risk
PREHAB: 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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|---|---|
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Infections and infestations
Sepsis
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
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Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
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General disorders
Fever
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
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Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
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Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
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Other adverse events
| Measure |
Supervised Prehabilitation Exercise Program
n=16 participants at risk
PREHAB: 6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour supervised training sessions made up of moderate intensity aerobic training and resistance training. In addition to the supervised sessions, patients will be instructed to accumulate a total of 150 minutes per week of moderate aerobic training at home which is measured by a wrist worn FitBit device.
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|---|---|
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Gastrointestinal disorders
Abdominal Pain
|
12.5%
2/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Investigations
Alanine Aminotransferase Increased
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Investigations
Alkaline Phosphatase Increased
|
12.5%
2/16 • Number of events 3 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Blood and lymphatic system disorders
Anemia
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Investigations
Blood Bilirubin Increased
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
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General disorders
Fatigue
|
37.5%
6/16 • Number of events 6 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
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Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Vascular disorders
Hyponatremia
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Gastrointestinal disorders
Nausea
|
18.8%
3/16 • Number of events 3 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Investigations
Platelet Count Decreased
|
6.2%
1/16 • Number of events 2 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
|
|
Ear and labyrinth disorders
Vertigo
|
6.2%
1/16 • Number of events 1 • PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place