NCT03215459

Brief Summary

Cardiopulmonary exercise testing (CPET) has been shown to be superior to American Society of Anaesthetist classification (ASA) in predicting peri-operative risk. The most common performance status used is the World Health Organisation (WHO) (0-4), with a clinician agreed differentiation of the subsets of 0-2 and 3-4; variability also exists within these subsets. With this there rises a concern that fit older patients may not be offered appropriate chemotherapy treatment. This observational study will assess whether cardiopulmonary exercise testing (CPET) offers additional benefit over that of WHO Performance status (PS) in the assessment of patients fitness for palliative chemotherapy for pancreatic cancer, by identifying those patients who might survive longer and tolerate chemotherapy better, thus predicting their outcome.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

June 19, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed
3.6 years until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

January 5, 2021

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

June 19, 2017

Last Update Submit

January 4, 2021

Conditions

Pancreatic Cancer

Keywords

Cardiopulmonary Exercise Testing

Outcome Measures

Primary Outcomes (4)

  • Survival at 6 months (followed up for 12mths)

    AUROC (Area under Receiver Operating Characteristic) for WHO (0-4) and WHO + CPET. A logistic regression model will be constructed, one with WHO PS and VO2 at AT (ml/kg/min).

    6 months

  • Survival at 6 months (followed up for 12mths)

    AUROC for WHO and WHO + CPET: A logistic regression model will be constructed with WHO PS and VO2 max (ml/kg/min).

    6 months

  • Survival at 6 months (followed up for 12mths)

    AUROC for WHO and WHO + CPET: A logistic regression model will be constructed with WHO PS and O2AT.

    6 months

  • Survival at 6 months (followed up for 12mths)

    The WHO+CPET classifier with the highest AUROC will then be compared with the AUROC for WHO alone.

    6 months

Secondary Outcomes (1)

  • Time-to-event endpoints

    6 months

Study Arms (1)

Cardiopulmonary Exercise Test

A cardiopulmonary exercise bike test will be administered prior to palliative chemotherapy treatment.

Device: Cardiopulmonary Exercise Test

Interventions

Cardiopulmonary Exercise TestDEVICE

Cardiopulmonary Exercise Test

Cardiopulmonary Exercise Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 patients from the UK who have Pancreatic cancer and are due to commence palliative chemotherapy

You may qualify if:

  • Histologically proven pancreatic cancer
  • Due to commence palliative chemotherapy (including as part of a Clinical Trial of an Investigational Medicinal Product (CTIMP)).
  • Able to undertake CPET
  • Expected life expectancy \>3 months
  • Age 18+

You may not qualify if:

  • Haemoglobin \<10g/L
  • Absolute contraindications for cardiopulmonary exercise testing:
  • Acute myocardial infarction (3-5 days)
  • Unstable angina
  • Uncontrolled arrhythmias causing symptoms or hemodynamic comprise
  • Syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Daniel Palmer, Professor

    Clatterbridge

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon A Winn, BSc

CONTACT

0151 7055264simon.winn@liv.ac.uk

Chloe Smith, BSc

CONTACT

0151 795 5293chloenyc@liverpool.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

July 12, 2017

Study Start

February 1, 2021

Primary Completion

August 1, 2022

Study Completion

September 1, 2023

Last Updated

January 5, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share