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The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.

18 Years
Not Enrolling
Effects of Chemotherapy, Cancer

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Trial Information

The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.

Purpose: To evaluate the effects of chemotherapy on pre−operative fitness of patients prior
to major cancer surgery.

Design: Patients will act as their own case−control.

Patients will be consented at the earliest available opportunity following the decision that
they have surgically treatable disease and they consent to pre−operative NAC. Consent for
the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is
our current standard practice, prior to commencing neoadjuvant chemotherapy. As part of the
assessment, they will have pulmonary function testing (static lung volumes, lung diffusing
capacity),and a nutritional assessment using bioimpedance measurements. They will then
undergo 3 cycles of NAC lasting a total of 6 weeks, as is standard current practice at our
institution. At "visit 2", approximately four to six weeks following chemotherapy and just
prior to planned surgery the CPET and other assessments will be repeated. This is also
current standard practice at our institution.

Data from visit 1 and visit 2 will be compared in a paired manner. A statistician will be
consulted to assess the degree of normality of the data, the statistical tests to use, and
for power calculations. At no point will any treatments be postponed or changed solely for
the purposes of collecting data for the research. 12 months survival will be assessed as an
outcome variable.

Inclusion Criteria:

- Consenting patients with surgically resectable oesophageal and gastric cancers
referred to a tertiary NHS referral service who are deemed by their clinician to be
suitable for pre−operative neoadjuvant chemotherapy(NAC)prior to their planned

Exclusion Criteria:

- Patients with cancers deemed to have surgically non−resectable disease, patients
refusing chemotherapy, patients unable to perform cardiopulmonary exercise testing
(CPET) due to other coincident illness or conditions (e.g. arthritis), patients
refusing surgery, patients withholding consent. Patients unable to give informed
consent due to mental incapacity. Prisoners will be excluded. Patients in whom
haemoglobin drops by >2g/dl between Visit 1 and visit 2.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

What is the effect of chemotherapy on the fitness of patients prior to cancer surgery?

Outcome Description:

Fitness will be assessed using "cardiopulmonary exercise testing", which is currently a routine part of our clinical practice in pre−operative assessment of patients prior to surgery.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

David Raw

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aintree University Hospitals NHS Foundation Trust, Liverpool, UK


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

August 2007

Completion Date:

August 2009

Related Keywords:

  • Effects of Chemotherapy
  • Cancer
  • Gastrointestinal Neoplasms