The Effect of Chemotherapy on Lactate Threshold in Cancer Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335555
• Other study ID #: 08/H1001/137
• Status: Completed
• Phase: N/A
• First received: April 11, 2011
• Last updated: April 18, 2011
• Start date: August 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2007
• Source: Aintree University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

It is important to assess patients' fitness for major cancer surgery which carries a high risk of mortality. Patients with poor heart and lung function have a higher risk of death after major cancer surgery. Cardiopulmonary exercise testing, CPET, is an objective measure of patients' fitness. Most patients, before surgery to resect their cancer, undergo a period of chemotherapy. Chemotherapy often regresses the cancer but also has adverse effects on cell function. Our hypothesis is that chemotherapy alters patient fitness, as assessed by CPET, prior to major cancer surgery. Participating patients will undergo fitness testing by CPET before and after their chemotherapy, prior to their surgery.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 surgery.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Effects of Chemotherapy

Locations

Country	Name	City	State
United Kingdom	Aintree University Hospitals	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Aintree University Hospitals NHS Foundation Trust	University Hospital Southampton NHS Foundation Trust.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	What is the effect of chemotherapy on the fitness of patients prior to cancer surgery?	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.	2 years	Yes
Secondary	Does good nutritional status following chemotherapy protect against any effect of chemotherapy?		2 years	Yes
Secondary	Survival outcome at 1 year		2 years	Yes