An interventional study of PREHAB in Pancreas Cancer, sponsored by Cedars-Sinai Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care
The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.
Attendance to exercise sessions as well as impacts on healthcare utilization, muscle mass, quality of life, physical activity, and post-operative outcomes when applicable will be monitored.
Study participants will participant in a supervised, in-person exercise program 3 times per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during the study and complete surveys and exercise tests at specified timepoints (Baseline, Post-Intervention Evaluation and 3-Month Follow Up).
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 16 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain portal only (failure to meet inclusion criterion below should not preclude subjects from participating in main study):
Exclusion Criteria:
Exclusion criteria for remote monitoring component of the study with Fitbit only (failure to meet exclusion criterion below should not preclude the subject from participating in main study):
Other: 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.
PREHAB Feasibility
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
Time frame: From Baseline to 3 Months
PREHAB Program Safety
PREHAB 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.
Time frame: From Baseline to 3 Months
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.
| Milestone | Supervised Prehabilitation Exercise Program |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
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
| Participants | Supervised Prehabilitation Exercise Program |
|---|---|
| PREHAB Feasibility | 10 |
PREHAB 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.
| Participants | Supervised Prehabilitation Exercise Program |
|---|---|
| Abdominal pain | 2 |
| Alanine aminotransferase increased | 1 |
| Alkaline phosphatase increased | 2 |
| Anemia | 2 |
| Aspartate aminotransferase increased | 1 |
| Back pain | 1 |
| Blood bilirubin increased | 1 |
| Confusion | 1 |
| Constipation | 1 |
| Diarrhea | 2 |
| Dizziness | 1 |
| Dyspnea | 1 |
| Fatigue | 6 |
| Fever | 1 |
| Headache | 1 |
| Hyperglycemia | 1 |
| Hypocalcemia | 1 |
| Hypokalemia | 1 |
| Hyponatremia | 1 |
| Hypotension | 1 |
| Nausea | 3 |
| Platelet Count Decreased | 1 |
| Sepsis | 1 |
| Vertigo | 1 |
Collected over PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Supervised Prehabilitation Exercise Program | 0/16 (0%) | 3/16 (18.8%) | 10/16 (62.5%) |
| Event | Supervised Prehabilitation Exercise Program |
|---|---|
| SepsisInfections and infestations | 1/16 |
| AnemiaBlood and lymphatic system disorders | 1/16 |
| FeverGeneral disorders | 1/16 |
| DiarrheaGastrointestinal disorders | 1/16 |
| ConfusionPsychiatric disorders | 1/16 |
| Event | Supervised Prehabilitation Exercise Program |
|---|---|
| FatigueGeneral disorders | 6/16 |
| NauseaGastrointestinal disorders | 3/16 |
| Abdominal PainGastrointestinal disorders | 2/16 |
| Alkaline Phosphatase IncreasedInvestigations | 2/16 |
| Alanine Aminotransferase IncreasedInvestigations | 1/16 |
| AnemiaBlood and lymphatic system disorders | 1/16 |
| Aspartate Aminotransferase IncreasedInvestigations | 1/16 |
| Back PainMusculoskeletal and connective tissue disorders | 1/16 |
| Blood Bilirubin IncreasedInvestigations | 1/16 |
| ConstipationGastrointestinal disorders | 1/16 |
| Age, Categorical(Participants) | Supervised Prehabilitation Exercise Program |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 11 |
| Age, Continuous(years) | Supervised Prehabilitation Exercise Program |
|---|---|
| Median | 70.5 (59 to 85) |
| Sex: Female, Male(Participants) | Supervised Prehabilitation Exercise Program |
|---|---|
| Female | 7 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Supervised Prehabilitation Exercise Program |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 14 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Supervised Prehabilitation Exercise Program |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Supervised Prehabilitation Exercise Program |
|---|---|
| United States | 16 |
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Cedars-Sinai Medical Center