Pancreas Cancer
Conditions
Keywords
Exercise, Prehabilitation
Brief summary
The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.
Detailed description
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).
Interventions
OTHERPREHAB
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.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pancreatic cancer diagnosis (any stage) * Age ≥ 18 years * Independent ambulation and activities of daily living (Discretion of referring/ treating oncologist) * Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23 * Physically able to complete functional assessments including 6-minute walk test, hand grip strength, short performance physical battery and performance metrics * Answers no to all questions on PAR-Q OR is cleared to participate by their treating oncologist * Ability to read, write and understand English * Written informed consent obtained from subject and ability for subjects to comply with the requirements of the study 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): * Access to a smart device capable of Fitbit syncing and accessing the online Pain portal (www.painguide.com)
Exclusion criteria
* Has undergone or plans to undergo resection surgery prior to projected completion of PREHAB exercise intervention * Current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PREHAB Feasibility | From Baseline to 3 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PREHAB Program Safety | From Baseline to 3 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPhilip Chang, DO
Cedars-Sinai Medical Center
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 70.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 10 / 16 |
| serious Total, serious adverse events | 3 / 16 |
Outcome results
None listed