The Effect of Chemotherapy on Lactate Threshold in Cancer Patients

NCT01335555 | Completed

• 1 other identifier: 08/H1001/137
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effects of Chemotherapy; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Does good nutritional status following chemotherapy protect against any effect of chemotherapy?

  2 years

• Survival outcome at 1 year

  2 years

Study Arms (1)

Patients Pre and Post-chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Upper gastrointestinal cancer patients receiving neoadjuvant chemotherapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• University Hospital Southampton NHS Foundation Trust: collaborator

Study Sites (1)

Aintree University Hospitals

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Related Publications (1)

• Jack S, West MA, Raw D, Marwood S, Ambler G, Cope TM, Shrotri M, Sturgess RP, Calverley PM, Ottensmeier CH, Grocott MP. The effect of neoadjuvant chemotherapy on physical fitness and survival in patients undergoing oesophagogastric cancer surgery. Eur J Surg Oncol. 2014 Oct;40(10):1313-20. doi: 10.1016/j.ejso.2014.03.010. Epub 2014 Mar 27.

  PMID: 24731268 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• David Raw

  Aintree University Hospitals NHS Foundation Trust, Liverpool, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 14, 2011
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 19, 2011

Record last verified: 2007-08

Locations

GB (1)