Prehab for Pancreatic Cancer Surgery

NCT07478185 | Not Yet Recruiting

• 1 other identifier: STUDY00002524
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Prehabilitation; Pancreatic Cancer, Adult

Keywords

Prehabilitation; Nutritional status; Functional capacity; Pancreatic cancer; Pancreatectomy; Pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (8)

• Change in 6-minute walk distance

  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

  Enrollment to preoperative assessment (up to 6 months after enrollment)

• 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)

• Change in body mass index (BMI)

  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

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

Study Arms (1)

Multimodal Prehabilitation Program

EXPERIMENTAL

Participants in this single-arm study will receive a structured prehabilitation program during neoadjuvant chemotherapy prior to planned pancreatic cancer surgery.

Behavioral: Multimodal Prehabilitation

Interventions

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.

Multimodal Prehabilitation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Pancreatic Cancer Alliance: collaborator

Study Sites (1)

UMass Memorial Medical Center

Worester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Pancreatic cancer, adult; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• James M Lindberg, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla R Widdowson, MD

CONTACT

774-641-1257; kayla.widdowson@umassmed.edu

James M Lindberg, MD

CONTACT

508-334-5220; james.lindberg@umassmemorial.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)