Clinical trial · Interventional
Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
NCT03865875CI-TRIAL-00051838unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (PDAC)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Program | Behavioral | — | UNRESOLVED |
| Nutrition Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multimodal Prehabilitation Program
- description
- Pretreatment exercise program and nutrition program -The prehabilitation intervention will include the following components: (1) a standardized fitness program and (2) nutritional counseling and optimization. Patients are enrolled in the program within 8 weeks of being diagnosed and continued until operation
- interventionNames
- Behavioral: Exercise Program
- Behavioral: Nutrition Program
Primary outcomes (1)
- measure
- Number of participants to complete prehabilitation program
- timeFrame
- 1 year
- description
- At least 50% (95% confidence interval +/- 16%) of participants will complete 50% of the components of the prehabilitation program.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Adults age 18 years or older. * Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN). * Planning to undergo TNT at MGH. * Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy. * Planning to undergo surgical resection of PDAC at MGH. * Verbal fluency in English. Exclusion Criteria * Metastatic disease. * Previous treatment for pancreas adenocarcinoma and no prior therapy for any cancer within 5 years. * Known history of cognitive or psychologic impairment. * Known history of physical impairment such as immobility, use of walking aids, or required wheelchair use. * Known history of the following orthopedic comorbidities: advanced osteoarthritis or rheumatoid arthritis, mobility-limiting amputations, orthopedic injuries, or widespread chronic pain (e.g. fibromyalgia). * Known history of the following pulmonary comorbidities: severe chronic obstructive pulmonary disease (COPD) defined as FEV1 ≤ 50%, emphysema, interstitial lung disease, and/or use of supplemental oxygen. * Known history of the following cardiovascular comorbidities: uncontrolled hypertension, severe congestive heart failure (NYHA Class IV), and/or myocardial infarction within the last 6 months. * Inability to tolerate diet through routine oral routes and/or patients with strict nutritional restrictions, allergies, and/or dietary preferences.
References
Publications (0)
Data not yet available
No reference posted for this study.