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NCT Number: NCT07478185

Prehab for Pancreatic Cancer Surgery

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.

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Key information

Conditions

Pancreatic Cancer, Adult Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Prehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center

Worester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Kayla R Widdowson, MD

CONTACT

[email protected]

774-641-1257

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal prehabilitation

Behavioral

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.

Primary outcomes

  1. Feasibility of prehabilitation program delivery

    Time frame: 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.

  2. Adherence to prehabilitation components

    Time frame: 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 outcomes

  1. 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.

    Assessed using American Thoracic Society guidelines, change by difference in meters of walking distance achieved.

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

    Time frame: 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.

  3. 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)

    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.

  4. Change in body mass index (BMI)

    Time frame: 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).

  5. 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)

    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.

  6. 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)

    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.

  7. Postoperative complications measured using Clavien-Dindo classification

    Time frame: 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.

  8. Postoperative hospital length of stay

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

    Days from surgery to discharge will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

James M Lindberg, MD

CONTACT

[email protected]

508-334-5220

Kayla R Widdowson, MD

CONTACT

[email protected]

774-641-1257

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Pancreatic Cancer Alliance

Registry information

Official study title

Multimodal Prehabilitation Prior to Pancreatic Cancer Surgery: A Pilot Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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