Clinical Trial 23088

• Overview

  Study Title:

  Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer: A Randomized Pilot Study

  Summary:

  The purpose of the study is to examine the feasibility and acceptability of an exercise and nutrition prehabilition program for patients preparing for pancreatic cancer resection (removal).

  Objective:

  Aim 1: Evaluate the feasibility and acceptability of PA/N and RT/N programs among patients preparing for PC resection. Feasibility metrics will include rates of recruitment (≥70%), retention (≥70%), and adherence to PA/RT prescriptions and nutrition monitoring (≥75%). Acceptability evaluation will include participant ratings of satisfaction for specific intervention components and qualitative data from semi-structured interviews. Aim 2: Examine exploratory outcomes (e.g., weight and body composition, aerobic and muscular fitness, physical functioning, nutritional status, QOL) and clinical characteristics (e.g., postoperative length of stay, surgical complications, receipt of adjuvant therapy) among PA/N and RT/N participants. Aim 3: Compare clinical and treatment outcomes (e.g., weight and body composition, serum albumin, postoperative length of stay, surgical complications, receipt of adjuvant therapy) between study participants and a retrospectively-identified, usual care comparison group.

• Inclusion Criteria

  Inclusion Criteria:
  • 18 years of age or older
  • Biopsy proven pancreatic ductal adenocarcinoma (PDAC), borderline resectable at diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Undergoing neoadjuvant chemotherapy with treatment plan including chemo radiation therapy and surgical resection
  • Ability to read and speak English

• Exclusion Criteria

  Exclusion Criteria:
  • Regular engagement in RT (2x/week targeting all major muscle groups)
  • Screen failure for exercise safety based on PAR-Q
  • Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
  • Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
  • Numeric pain rating scale of more than 7 out of 10
  • Myopathic or rheumatologic disease that impacts physical function

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