Exercise to Improve Outcomes in Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Surrey
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
<18 years age
Cardiopulmonary exercise test (CPET) contraindications
Physical inability to perform CPET or undertake the program.
Lacking the capacity to consent
Trial design
Design model
Single group
Treatments tested in this trial
ExO-PanC Personalised Exercise Programme
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the ExO-PanC exercise programme
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.
Time frame
From enrolment until completion of the intervention (approximately 16-24 weeks)Secondary outcomes
1
Postoperative surgical complications
Occurrence and severity of postoperative complications, including pancreatic fistula and other clinically relevant surgical complications
Time frame
Up to approximately 6 weeks following surgery.2
Commencement and completion of adjuvant chemotherapy
Proportion of participants who commence planned adjuvant chemotherapy following pancreaticoduodenectomy and proportion who complete it
Time frame
From surgery until planned commencement and completion of adjuvant chemotherapy.3
Cardiorespiratory fitness (CRF) measured by cardiopulmonary excercise testing (CPET)
Difference in anaerobic threshold (mL/kg/min) and peak oxygen uptake (VO₂peak, mL/kg/min) measured during CPET.
Time frame
Baseline through completion of the intervention (approximately 16-24 weeks)4
Muscle strength
Changes in upper and lower body muscle strength measured using standardised strength assessments.
Time frame
Baseline through completion of the intervention (approximately 16-24 weeks).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Surrey
Lead sponsor
Royal Surrey County Hospital NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov