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Prehab for Pancreatic Cancer Surgery

ConditionsPancreatic Cancer, AdultPrehabilitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age <18 years

Pregnant

Prisoner

Severe cognitive impairment that precludes informed consent or participation

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Multimodal Prehabilitation ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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 outcomes

1

Change in 6-minute walk distance

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

Time frame
Baseline enrollment (pre-prehabilitation) to preoperative assessment (after completion of prehabilitation) up to 6 months after enrollment.
2

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

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.

Time frame
Enrollment to preoperative assessment (up to 6 months after enrollment)
3

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

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.

Time frame
Baseline, preoperative assessment, postoperative follow up (up to 1 year after enrollment)
4

Change in body mass index (BMI)

Height in meters and weight in kilograms will be used to calculate BMI (kg/m\^2).

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

UMass Memorial Medical CenterRecruiting01655, Worester, MassachusettsUnited StatesUnited States

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

Pancreatic Cancer Alliance

Collaborator

Source ClinicalTrials.gov
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