Pancreatic Cancer, Adult, Prehabilitation
Conditions
Keywords
Prehabilitation, Nutritional status, Functional capacity, Pancreatic cancer, Pancreatectomy, Pancreaticoduodenectomy
Brief summary
The goal of this clinical study is to test whether a structured prehabilitation program can be successfully used by adults with pancreatic cancer who are receiving chemotherapy before planned surgery. Prehabilitation is a program designed to improve a person's physical fitness, nutrition, and symptom control before surgery. The study's main hypothesis is that patients with pancreatic cancer can take part in and adhere to a multimodal prehabilitation program during chemotherapy, and that doing so may improve physical function, patient experience, and early recovery after surgery.
Detailed description
This is a single-center, prospective pilot study designed to evaluate the implementation of a standardized, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to pancreatic cancer surgery. The intervention is integrated into routine preoperative care and includes coordinated physical activity, nutritional optimization, and supportive care components delivered throughout the neoadjuvant treatment period. Assessments are performed at baseline, after completion of the prehabilitation period and before surgery, and approximately one month after surgery to characterize participation, intervention delivery, and perioperative changes in functional and clinical measures. Data collection includes standardized functional fitness assessments, patient-reported surveys, and abstraction of perioperative clinical data from the electronic medical record. Analyses are descriptive and exploratory, reflecting the pilot nature of the study, and are intended to characterize feasibility, adherence, and variability of measured outcomes rather than to test efficacy. Findings from this study will be used to refine intervention delivery, identify logistical and patient-level barriers, and inform the design of future larger-scale studies evaluating prehabilitation in pancreatic cancer surgery.
Interventions
BEHAVIORALMultimodal Prehabilitation
Participants will receive a structured, multimodal prehabilitation program delivered during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery. The program integrates supervised, individualized exercise training, nutritional assessment and counseling with recommended preoperative immunonutrition, and supportive care focused on symptom management and functional support. Prehabilitation is delivered as an integrated component of preoperative care and continues through completion of neoadjuvant therapy until surgery.
Sponsors
University of Massachusetts, Worcester
Pancreatic Cancer Alliance
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
* Age ≥ 18 years * Diagnosis of pancreatic ductal adenocarcinoma (PDAC) * Planned neoadjuvant chemotherapy prior to planned surgical resection * Medically stable and cleared to participate in physical activity/exercise programming * Able to provide informed consent * Ability to read, write and understand English
Exclusion criteria
* Age \<18 years * Pregnant * Prisoner * Severe cognitive impairment that precludes informed consent or participation * Contraindications to physical activity, including unstable cardiac disease, severe pulmonary disease, or recent myocardial infarction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of prehabilitation program delivery | From enrollment through completion of neoadjuvant therapy (approximately 3-6 months) | Feasibility will be assessed by the proportion of enrolled participants who initiate and complete the prehabilitation program during neoadjuvant chemotherapy prior to surgery. |
| Adherence to prehabilitation components | From enrollment through preoperative assessment (approximately 3-6 months) | Adherence will be measured by participant-reported completion of prescribed exercise sessions and reported completion of recommended preoperative immunonutrition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6-minute walk distance | Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment. | Assessed using American Thoracic Society guidelines, change by difference in meters of walking distance achieved. |
| Change in Fried Frailty phenotype between enrollment and pre-operative evaluation | Enrollment to preoperative assessment (up to 6 months after enrollment) | The Fried Frailty Phenotype is a five-component measure used to classify frailty status. Patients are evaluated for unintentional weight loss, weakness, slowness, poor endurance, and low physical activity (each criteria are assigned one point). A score of 0 is considered "not-frail," and a score of 1 or 2 is considered "prefrail" or at risk of frailty. A score of 3 or more meets the diagnosis of frail. The maximum possible score is 5 and higher scores indicate more frail. |
| Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA) | Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment) | The PG-SGA SF consists of four boxes: box 1, questions regarding body weight (scored 0-5); box 2, food intake (score 0-4); box 3, symptoms affecting oral food intake (scored 0-23); and box 4, regarding activities and function (score 0-4). The sum of these four boxes can range from 0 to 36 points, with the higher the score, the greater the nutritional risk. |
| Change in body mass index (BMI) | Enrollment, preoperative assessment, through postoperative follow up, up to 1 year after enrollment | Height in meters and weight in kilograms will be used to calculate BMI (kg/m\^2). |
| Change in physical functioning measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a | Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment) | 10-item questionnaire assessing current self-reported physical function. Raw scores are translated into T-scores, with a mean of 50 and a standard deviation of 10, for comparison with the U.S. general population mean. A higher T-score represents better physical function. |
| Change in health related quality of life measured by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score | Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment) | FACT-Hep is a a 45-item self-report instrument designed to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers. Scores range from 0-180 where higher scores indicate greater quality of life. |
| Postoperative complications measured using Clavien-Dindo classification | Up to 30 days after surgery (up to 1 year after enrollment) | Clavien-Dindo classification is a standardized system used to grade postoperative complications based on the type of intervention required to manage the complication, rather than on the complication itself. Scores range from zero to five with higher scores indicating more severe. Highest severity complication according to Clavien-Dindo classification will be recorded. |
| Postoperative hospital length of stay | Up to 90 days postoperative (up to 14 months after enrollment) | Days from surgery to discharge will be recorded |
Countries
United States
Contacts
CONTACTKayla R Widdowson, MD
CONTACTJames M Lindberg, MD
PRINCIPAL_INVESTIGATORJames M Lindberg, MD
UMass Memorial Health
Outcome results
None listed