The Effect of Chemotherapy on Lactate Threshold in Cancer Patients
|ClinicalTrials.gov Identifier: NCT01335555|
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : April 19, 2011
|Condition or disease|
|Effects of Chemotherapy 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.
|Study Type :||Observational|
|Actual Enrollment :||89 participants|
|Official Title:||The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
|Patients Pre and Post-chemotherapy|
- What is the effect of chemotherapy on the fitness of patients prior to cancer surgery? [ Time Frame: 2 years ]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.
- Does good nutritional status following chemotherapy protect against any effect of chemotherapy? [ Time Frame: 2 years ]
- Survival outcome at 1 year [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335555
|Aintree University Hospitals|
|Liverpool, Merseyside, United Kingdom, L9 7AL|
|Principal Investigator:||David Raw||Aintree University Hospitals NHS Foundation Trust, Liverpool, UK|