Oesophageal AdenocarcinomaOeso-ChemoNCT01742312
Effects of Chemotherapy on Muscle Mass and Exercise Performance in Patients With Oesophageal Cancer.
An observational study of Oesophageal Adenocarcinoma, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oesophageal Adenocarcinoma
- What is being tested?
- DEXA scan, Muscle biopsy and cardio-pulmonary exercise testing (CPEX)
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Jan 2013
- 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: healthy volunteers oesophageal cancer patients
Who may be able to join
- oesophageal cancer
- Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery
Who cannot join
- Metastatic disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Graduate Entry Medical School, University of Nottingham
Derby, Derbyshire, DE33 2NE
About this study
Official title: Effect of Neoadjuvant Chemotherapy on Muscle Mass and Peri-operative Cardiorespiratory Performance in Patients Undergoing Oesophageal Cancer- a Pilot Study
Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.
Read the detailed description
We aim to review the effects of chemotherapy on skeletal muscle mass and cardio-respiratory performance in patients with oesophageal adenocarcinoma. All patients will be assessed by a Consultant Anaesthetist and a medical member of the Research team before commencing chemotherapy and after finishing their course. These assessments include a nutritional assessment, performance status assessments, blood assays, dual energy X-ray absorptiometry (DEXA) scans, cardio-pulmonary exercise (CPEX) testing and a muscle biopsy.
- Conditions
- Oesophageal Adenocarcinoma
- Being tested
- DEXA scan, Muscle biopsy, cardio-pulmonary exercise testing (CPEX)
- Keywords
- neoadjuvant chemotherapy, oesophageal cancer, cardiorespiratory performance
- Medical subject headings
- Adenocarcinoma Of Esophagus, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA scanRadiation
all patients will undertake a full body DEXA scan before and after chemotherapy
Muscle biopsyProcedure or surgery
All patients will have a muscle biopsy before and after chemotherapy
cardio-pulmonary exercise testing (CPEX)Other
patients will undertake exercise in the form of an exercise bike whilst having their cardiac and ventilatory performance analysed. This will take place before and after neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| oesophageal adenocarcinoma | DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy Receives: Radiation: DEXA scan; Procedure: Muscle biopsy; Other: cardio-pulmonary exercise testing (CPEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
variations in muscle mass during neoadjuvant chemotherapy
Measured: 3 months
Secondary outcomes (4)
nutritional status
assess nutritional status post chemotherapy via serum protein levels.
Measured: 3 months
all cause mortality
Evidence of mortality and relate this to aerobic ability.
Measured: 3 months
mitochondrial function performance status
review changes in mitochondrial function after neoadjuvant chemotherapy
Measured: 3 months
cardiorespiratory performance (peak VO2)
review changes in cardiorespiratory performance (peak VO2) after neoadjuvant chemotherapy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- John Williams, MBChB, FFPMRCA, PhD, Study chair, Graduate Entry Medical School, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742312
- Sponsor's protocol ID
- 10/H0405/38
- Acronym
- Oeso-Chemo
- Status last verified
- Feb 2016
- First submitted
- 3 Dec 2012
- Last updated
- 18 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neoadjuvant Chemotherapy on Muscle Mass and Peri-operative Cardiorespiratory Performance in Patients Undergoing Oesophageal Cancer- a Pilot Study
- ClinicalTrials.gov ID
- NCT01742312
- Acronym / sponsor ID
- Oeso-Chemo / 10/H0405/38
- Conditions
- Oesophageal Adenocarcinoma
- Keywords
- neoadjuvant chemotherapy, oesophageal cancer, cardiorespiratory performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Dec 2012 (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.
Curative treatment for oesophageal cancer involves undertaking chemotherapy followed by an operation to remove the tumour. Chemotherapy has several effects upon the body, including effects upon the systems that control the creation and breakdown of muscle. We aim to review these effects by recording changes in the amount of exercise patients are able to undertake after chemotherapy and reviewing changes in muscle mass.
Detailed description
We aim to review the effects of chemotherapy on skeletal muscle mass and cardio-respiratory performance in patients with oesophageal adenocarcinoma. All patients will be assessed by a Consultant Anaesthetist and a medical member of the Research team before commencing chemotherapy and after finishing their course. These assessments include a nutritional assessment, performance status assessments, blood assays, dual energy X-ray absorptiometry (DEXA) scans, cardio-pulmonary exercise (CPEX) testing and a muscle biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oesophageal adenocarcinoma | – | Radiation: DEXA scan, Procedure: Muscle biopsy, Other: cardio-pulmonary exercise testing (CPEX)DEXA scan cardio-pulmonary exercise testing (CPEX) muscle biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers oesophageal cancer patients
Key inclusion criteria (2 listed)
- oesophageal cancer
- Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery
Key exclusion criteria (1 listed)
- Metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA scanall patients will undertake a full body DEXA scan before and after chemotherapy | Radiation | oesophageal adenocarcinoma |
| Muscle biopsyAll patients will have a muscle biopsy before and after chemotherapy | Procedure or surgery | oesophageal adenocarcinoma |
| cardio-pulmonary exercise testing (CPEX)patients will undertake exercise in the form of an exercise bike whilst having their cardiac and ventilatory performance analysed. This will take place before and after neoadjuvant chemotherapy | Other | oesophageal adenocarcinoma |
Primary outcome
muscle mass
Time frame: 3 months
variations in muscle mass during neoadjuvant chemotherapy
4 secondary outcomes
nutritional status
Time frame: 3 months
all cause mortality
Time frame: 3 months
mitochondrial function performance status
Time frame: 3 months
cardiorespiratory performance (peak VO2)
Time frame: 3 months
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 18 Feb 2016.
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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.
John Williams, MBChB, FFPMRCA, PhD study chair
Graduate Entry Medical School, University of Nottingham
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 Oesophageal Adenocarcinoma, run by University of Nottingham 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 2 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 18 Feb 2016. 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?
muscle mass (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2016.