NCT07710495

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
47mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jun 2030

First Submitted

Initial submission to the registry

July 6, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

July 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2.9 years

First QC Date

July 6, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

prehabilitationrehabilitationexercise

Outcome Measures

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.

    From enrolment until completion of the intervention (approximately 16-24 weeks)

Secondary Outcomes (7)

  • Postoperative surgical complications

    Up to approximately 6 weeks following surgery.

  • Commencement and completion of adjuvant chemotherapy

    From surgery until planned commencement and completion of adjuvant chemotherapy.

  • Cardiorespiratory fitness (CRF) measured by cardiopulmonary excercise testing (CPET)

    Baseline through completion of the intervention (approximately 16-24 weeks)

  • Muscle strength

    Baseline through completion of the intervention (approximately 16-24 weeks).

  • Change in health-related quality of life measured using the EORTC QLQ-C30

    Serial measurements from baseline through completion of the intervention (approximately 16-24 weeks).

  • +2 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Behavioral: ExO-PanC Personalised Exercise Programme

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Surrey

Guildford, Surrey, GU27XH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Adam E Frampton, PhD

    University of Surrey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarak AM Chouari, BSc (Hons) MBChB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 17, 2026

Study Start

July 6, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

Locations