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RecruitingInterventional

Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study

NCT ID: NCT07478185Sponsor: University of Massachusetts, WorcesterLast updated: 2026-04-03

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.

Arms & 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.

Outcome measures

Primary

  • Feasibility of prehabilitation program delivery

    Feasibility will be assessed by the proportion of enrolled participants who initiate and complete the prehabilitation program during neoadjuvant chemotherapy prior to surgery.

    Time frame: From enrollment through completion of neoadjuvant therapy (approximately 3-6 months)

  • Adherence to prehabilitation components

    Adherence will be measured by participant-reported completion of prescribed exercise sessions and reported completion of recommended preoperative immunonutrition.

    Time frame: From enrollment through preoperative assessment (approximately 3-6 months)

Secondary

  • Change in 6-minute walk distance

    Time frame: Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment.

  • Change in Fried Frailty phenotype between enrollment and pre-operative evaluation

    Time frame: Enrollment to preoperative assessment (up to 6 months after enrollment)

  • Change in nutritional status using the Patient Generated-Subjective Global Assessment (PG-SGA)

    Time frame: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)

  • Change in body mass index (BMI)

    Time frame: Enrollment, preoperative assessment, through postoperative follow up, up to 1 year after enrollment

  • Change in physical functioning measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 10a

    Time frame: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)

  • Change in health related quality of life measured by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) score

    Time frame: Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)

  • Postoperative complications measured using Clavien-Dindo classification

    Time frame: Up to 30 days after surgery (up to 1 year after enrollment)

  • Postoperative hospital length of stay

    Time frame: Up to 90 days postoperative (up to 14 months after enrollment)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

UMass Memorial Medical Center

Worester, Massachusetts, 01655

Recruiting
Kayla R Widdowson, MD · Contact
774-641-1257kayla.widdowson@umassmed.edu