The Effect of Chemotherapy on Lactate Threshold in Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
University Hospital Southampton NHS Foundation Trust.
Information provided by:
Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01335555
First received: April 11, 2011
Last updated: April 18, 2011
Last verified: August 2007
  Purpose

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.


Condition
Effects of Chemotherapy
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.

Resource links provided by NLM:


Further study details as provided by Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • What is the effect of chemotherapy on the fitness of patients prior to cancer surgery? [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Does good nutritional status following chemotherapy protect against any effect of chemotherapy? [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Survival outcome at 1 year [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients Pre and Post-chemotherapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Upper gastrointestinal cancer patients receiving neoadjuvant chemotherapy

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335555

Locations
United Kingdom
Aintree University Hospitals
Liverpool, Merseyside, United Kingdom, L9 7AL
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust.
Investigators
Principal Investigator: David Raw Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
  More Information

No publications provided

Responsible Party: MS. Michelle Mossa, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01335555     History of Changes
Other Study ID Numbers: 08/H1001/137
Study First Received: April 11, 2011
Last Updated: April 18, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on August 19, 2014