Remote Exercise and Nutritional Prehabilitation for Pancreatic Cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06423963

Enrollment

Registered

2024-05-21

Start date

2024-02-09

Completion date

2027-01-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Brief summary

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

Interventions

BEHAVIORALPhysical Activity

Each participant will receive a Fitbit device with instruction and encouragement to self-monitor physical activity using step counts.

BEHAVIORALNutrition Counseling

Participants will receive nutritional counseling with a registered dietician.

BEHAVIORALResistance Training

Participants will engage in progressive, full-body resistance training based on American College of Sports Medicine (ACSM) guidelines.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years 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 chemoradiation therapy and surgical resection * Ability to read and speak English

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 greater than or equal to a 7 out of 10 * Myopathic or rheumatologic disease that impacts physical function

Design outcomes

Primary

Measure	Time frame	Description
Feasibility and acceptability of PA/N and RT/N programs	Up to 16 weeks	The number of participants who complete T1 and T0 measures.

Secondary

Measure	Time frame	Description
Examine exploratory outcomes and clinical characteristics	Up to 16 weeks	The number of participants who demonstrate improvements in exploratory outcome measures.
Compare clinical and treatment outcomes	Up to 16 weeks	Chi-Square testing will be used to determine if there's a significant difference in outcomes between the treatment group and a usual care comparison group.

Countries

United States

Contacts

CONTACTMorgan Bean

morgan.bean@moffitt.org813-745-1786

PRINCIPAL_INVESTIGATORNathan Parker, PhD

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORPamela Hodul, MD