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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised Prehabilitation Exercise Program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREHAB | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From Baseline to 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to 3 Months |
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Inclusion Criteria:
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):
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| Name | Affiliation | Role |
|---|---|---|
| Philip Chang, DO | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | From Baseline to 3 Months |
|
PREHAB session 1 through to the 3 Month Follow-Up, an average of 5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philip Chang | Cedars-Sinai Medical Center | 310-467-4498 | philip.chang@csmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2025 | Mar 4, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 24, 2023 | Mar 4, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | From Baseline to 3 Months |
|
|
|
| 0 |
| 16 |
| 3 |
| 16 |
| 10 |
| 16 |
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Confusion | Psychiatric disorders | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Alkaline Phosphatase Increased | Investigations | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blood Bilirubin Increased | Investigations | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatremia | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Platelet Count Decreased | Investigations | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| Title | Measurements |
|---|---|
|
| Anemia |
|
| Aspartate aminotransferase increased |
|
| Back pain |
|
| Blood bilirubin increased |
|
| Confusion |
|
| Constipation |
|
| Diarrhea |
|
| Dizziness |
|
| Dyspnea |
|
| Fatigue |
|
| Fever |
|
| Headache |
|
| Hyperglycemia |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hyponatremia |
|
| Hypotension |
|
| Nausea |
|
| Platelet Count Decreased |
|
| Sepsis |
|
| Vertigo |
|