- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07710495
Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC)
Exercise-Based Pre-, Peri- and Post-Surgery Intervention to Improve Clinical and Translational Outcomes in Patients Undergoing Whipple's Procedure: A Feasibility Study.
Pancreatic cancer surgery (Whipple's procedure) is a major operation that can lead to reduced physical fitness, delayed recovery, and difficulty starting chemotherapy after surgery. Exercise before and after surgery may help improve recovery, but it is not known whether a personalised exercise programme delivered throughout the surgical pathway is practical or acceptable for patients.
The Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC) study is a single-arm feasibility study that will recruit adults with suspected pancreatic ductal adenocarcinoma who are scheduled to undergo Whipple's procedure. Participants will receive an individualised exercise programme before surgery, during their hospital stay, and after discharge until the start of adjuvant chemotherapy. The programme will include aerobic exercise and resistance training prescribed according to each participant's fitness level.
The primary objective is to determine whether this exercise programme is feasible by assessing recruitment, participant adherence, compliance with the prescribed exercise programme, and retention. Secondary exploratory objectives include evaluating surgical complications, initiation of adjuvant chemotherapy, physical fitness, quality of life, nutritional status, and blood, stool, and tumour biomarkers associated with clinical outcomes. Findings from this feasibility study will inform the design of a future multicentre randomised controlled trial evaluating the effectiveness of the ExO-PanC programme.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor survival, reduced physical function, and a high burden of treatment-related morbidity. Patients undergoing pancreaticoduodenectomy (Whipple's procedure) often experience substantial declines in cardiorespiratory fitness and muscle function before and after surgery, which may contribute to postoperative complications, delayed recovery, and reduced likelihood of receiving adjuvant chemotherapy. While prehabilitation programmes are increasingly incorporated into routine care, current approaches are not typically individualised using objective measures of physical fitness and generally do not extend across the entire perioperative pathway.
The Exercise to Improve Outcomes in Pancreatic Cancer (ExO-PanC) study has been developed to evaluate the feasibility of a personalised exercise programme delivered before surgery, during hospital admission, and throughout postoperative recovery until the commencement of adjuvant chemotherapy. Exercise prescriptions will be individualised using cardiopulmonary exercise testing (CPET), muscle strength assessments, and functional performance measures, allowing exercise intensity and progression to be tailored to each participant's physiological capacity.
Participants will undergo repeated assessments of cardiorespiratory fitness, physical function, muscle strength, nutritional status, quality of life, and biological sampling throughout the study. Blood, stool, and surgically resected tumour tissue will be collected to explore biomarkers associated with clinical outcomes and responses to exercise.
The primary objective of this feasibility study is to determine whether the ExO-PanC intervention can be successfully delivered across the perioperative pathway by evaluating participant recruitment, adherence, compliance with prescribed exercise, and study retention. Exploratory analyses will investigate surgical complications, initiation of adjuvant chemotherapy, changes in physical fitness and quality of life, and relationships between biological markers and clinical outcomes.
Results from this study will establish the feasibility of implementing a personalised perioperative exercise programme for patients undergoing pancreatic cancer surgery and will provide essential data to inform the design of a future adequately powered multicentre randomised controlled trial evaluating the effectiveness of the ExO-PanC intervention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tarak AM Chouari, BSc (Hons) MBChB
- Phone Number: 01483688691
- Email: t.chouari@nhs.net
Study Locations
-
-
Surrey
-
Guildford, Surrey, United Kingdom, GU27XH
- Recruiting
- University of Surrey
-
Contact:
- Tarak AM Chouari, BSc(Hons) MBChB
- Phone Number: 01483688691
- Email: t.chouari@nhs.net
-
Sub-Investigator:
- Tarak AM Chouari, BSc(Hons) MBChB
-
Principal Investigator:
- Adam E Frampton, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Planned to undergo upfront pancreatoduodenectomy (Whipple's procedure) for a suspected malignant periampullary mass.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- <18 years age
- Cardiopulmonary exercise test (CPET) contraindications
- Physical inability to perform CPET or undertake the program.
- Lacking the capacity to consent
- Unable to understand instructions in English
- Not scheduled for surgery
- A new diagnosis of Type 1 or Type 3c diabetes requiring management with insulin prescription will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
Participants will receive the ExO-PanC personalised exercise programme in addition to standard perioperative care.
The intervention comprises four phases spanning the surgical pathway: prehabilitation before surgery, supervised inpatient exercise following surgery, structured home-based recovery after hospital discharge, and rehabilitation before commencement of adjuvant chemotherapy.
Exercise is individually prescribed using cardiopulmonary exercise testing (CPET), muscle strength, and functional assessments, and includes aerobic and resistance with progression tailored to each participant's physical capacity.
Participants also undergo repeated assessments of physical fitness, quality of life, nutritional status, and collection of blood, stool, and tumour tissue samples throughout the study.
|
Participants will receive the ExO-PanC personalised exercise programme alongside standard perioperative care.
The intervention comprises four phases delivered across the surgical pathway: (1) prehabilitation before surgery, (2) supervised exercise during postoperative hospital admission, (3) structured home-based recovery following hospital discharge, and (4) rehabilitation before the commencement of adjuvant chemotherapy.
Exercise prescriptions are individualised using cardiopulmonary exercise testing (CPET), muscle strength, and functional assessments.
The programme includes aerobic, resistance, flexibility, and home-based exercise, with intensity and progression tailored to each participant's fitness level.
Exercise may be delivered in supervised or semi-supervised formats, with heart rate monitoring used to support exercise prescription and progression.
Participants continue to receive all standard NHS perioperative care throughout the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the ExO-PanC exercise programme
Time Frame: From enrolment until completion of the intervention (approximately 16-24 weeks)
|
Feasibility will be assessed using participant recruitment, adherence to the prescribed exercise programme (target >85% of prescribed sessions completed), compliance with prescribed exercise intensity, duration and type (target >80%), and participant retention (target <20% withdrawal for non-clinical reasons).
Feasibility will be evaluated separately across the preoperative, perioperative and postoperative phases of the intervention.
|
From enrolment until completion of the intervention (approximately 16-24 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative surgical complications
Time Frame: Up to approximately 6 weeks following surgery.
|
Occurrence and severity of postoperative complications, including pancreatic fistula and other clinically relevant surgical complications
|
Up to approximately 6 weeks following surgery.
|
|
Commencement and completion of adjuvant chemotherapy
Time Frame: From surgery until planned commencement and completion of adjuvant chemotherapy.
|
Proportion of participants who commence planned adjuvant chemotherapy following pancreaticoduodenectomy and proportion who complete it
|
From surgery until planned commencement and completion of adjuvant chemotherapy.
|
|
Cardiorespiratory fitness (CRF) measured by cardiopulmonary excercise testing (CPET)
Time Frame: Baseline through completion of the intervention (approximately 16-24 weeks)
|
Difference in anaerobic threshold (mL/kg/min) and peak oxygen uptake (VO₂peak, mL/kg/min) measured during CPET.
|
Baseline through completion of the intervention (approximately 16-24 weeks)
|
|
Muscle strength
Time Frame: Baseline through completion of the intervention (approximately 16-24 weeks).
|
Changes in upper and lower body muscle strength measured using standardised strength assessments.
|
Baseline through completion of the intervention (approximately 16-24 weeks).
|
|
Change in health-related quality of life measured using the EORTC QLQ-C30
Time Frame: Serial measurements from baseline through completion of the intervention (approximately 16-24 weeks).
|
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Change in EORTC QLQ-C30 global health status, functional scales and symptom scales.
Scores range from 0-100.
|
Serial measurements from baseline through completion of the intervention (approximately 16-24 weeks).
|
|
Nutritional status
Time Frame: Baseline through completion of the intervention (approximately 16-24 weeks).
|
Nutritional status assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF).
|
Baseline through completion of the intervention (approximately 16-24 weeks).
|
|
Change in pancreatic cancer-specific quality of life measured using the EORTC QLQ-PAN26
Time Frame: This will be measured at five timepoints from recruitment through to commencement of adjuvant chemotherapy
|
Serial changes in EORTC QLQ-PAN26 symptom scores.
Scores range from 0-100.
|
This will be measured at five timepoints from recruitment through to commencement of adjuvant chemotherapy
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adam E Frampton, PhD, University of Surrey
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 350182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Deconditioning
-
SingHealth Community HospitalsRebee Health; Jurong Community HospitalNot yet recruitingAI-Assisted TelerehabiLitAtion System (ATLAS) for Post-discharge Continuation of Rehabilitative CareRehabilitation | Deconditioning
-
Spital Thurgau AGNot yet recruitingPhysical Deconditioning
-
Swiss Federal Institute of TechnologyCompletedCardiovascular Deconditioning
-
Sergio Martinez-HuenchullanUniversidad Austral de ChileCompletedPhysical DeconditioningChile
-
University of Colorado, DenverTerminatedPhysical DeconditioningUnited States
-
VA Office of Research and DevelopmentCompletedPhysical Deconditioning | MultimorbidityUnited States
-
Singapore General HospitalNational Medical Research Council (NMRC), SingaporeUnknownDeconditioning, Isolation Precautions
-
VA Office of Research and DevelopmentNot yet recruitingPhysical Deconditioning | Mobility DeclineUnited States
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedPhysical Deconditioning | Older AdultsUnited States
-
University of SouthamptonActive, not recruitingDeconditioning | Orthopaedic Injuries | Orthopedic Fractures | Hospital Associated DeconditioningUnited Kingdom
Clinical Trials on ExO-PanC Personalised Exercise Programme
-
University of AberdeenVersus ArthritisCompletedRheumatoid Arthritis | Lupus Erythematosus, Systemic | Psoriatic Arthritis | Sjogren's Syndrome | Axial SpondyloarthritisUnited Kingdom
-
Joey PorterNot yet recruiting
-
Radboud University Medical CenterUniversità di PaviaNot yet recruiting
-
Hacettepe UniversityCompleted
-
NHS Greater Glasgow and ClydeUniversity of GlasgowCompletedGluteal TendinitisUnited Kingdom
-
University of GlasgowRecruiting
-
Aarhus University HospitalCompletedArthritis, RheumatoidDenmark
-
Instituto Sexológico MurcianoUniversidad Miguel Hernandez de ElcheCompletedPremature Ejaculation | Cognitive-Behavior Treatment | Masturbation Aid DeviceSpain
-
Hacettepe UniversityEnrolling by invitationKnee OsteoarthritisTurkey (Türkiye)
-
University College DublinCompletedExercise | Mobile ApplicationsIreland