Effects of ChemotherapyNCT01335555
The Effect of Chemotherapy on Lactate Threshold in Cancer Patients
An observational study of Effects of Chemotherapy and Cancer, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effects of Chemotherapy, Cancer
- How many people
- 89 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Upper gastrointestinal cancer patients receiving neoadjuvant chemotherapy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aintree University Hospitals
Liverpool, Merseyside, L9 7AL
About this study
Official title: The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.
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.
Read the 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.
- Conditions
- Effects of Chemotherapy, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients Pre and Post-chemotherapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (2)
Does good nutritional status following chemotherapy protect against any effect of chemotherapy?
Measured: 2 years
Survival outcome at 1 year
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startAug 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Investigators
- David Raw, Principal investigator, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335555
- Sponsor's protocol ID
- 08/H1001/137
- Status last verified
- Aug 2007
- First submitted
- 11 Apr 2011
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24731268
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neoadjuvant Chemotherapy on Lactate Threshold in Patients With Surgically Resectable Upper Gastrointestinal Cancer.
- ClinicalTrials.gov ID
- NCT01335555
- Acronym / sponsor ID
- 08/H1001/137
- Conditions
- Effects of Chemotherapy, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- Aug 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Pre and Post-chemotherapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Upper gastrointestinal cancer patients receiving neoadjuvant chemotherapy
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
- Derived from this study: PubMed 24731268Jack 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Raw principal investigator
Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of Chemotherapy and Cancer, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What is the effect of chemotherapy on the fitness of patients prior to cancer surgery? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.