Oesophageal AdenocarcinomaPre-EMPTNCT03626610
Prehabilitation of Patients With oEsophageal Malignancy Undergoing Peri-operative Treatment
A study testing Exercise prehabilitation during chemotherapy before surgery in people with Oesophageal Adenocarcinoma and Chemotherapy Effect, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
'Pre-EMPT' - A cohort-controlled, interventional study to assess the effects of a pre-emptive exercise programme, or 'prehabilitation', in patients undergoing peri-operative chemotherapy for adenocarcinoma of the lower oesophagus and gastro-oesophageal junction. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Oesophageal Adenocarcinoma, Chemotherapy Effect, Surgery
- What is being tested?
- Exercise prehabilitation during chemotherapy before surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2016to Jun 2021
- Phase
- Interventional
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be diagnosed with operable oesophageal and gastro-oesophageal adenocarcinoma and scheduled to undergo standard neo-adjuvant chemotherapy and oesophago-gastric surgery as recommended by the Multidisciplinary Meeting decision.
- 18+
- </=79 (patients above this age may be included in studies after the feasibility study has been completed)
- Participants must be able to understand and independently consent to participation in the study.
- Participants must be able to understand and complete the questionnaires.
- Participants must be willing to undergo all the standard assessments and interventions included in this study - CPEX testing, blood sampling, questionnaires and exercise intervention where appropriate.
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- Participants must be willing to wear the Fibit monitoring device and agree with its use
- Participants must be ASA 1-3 and fit for surgical resection
- Patients should have a Body Mass Index (BMI) equal to or above 18.5 with less than 10% self-reported unintentional weight loss at diagnosis.
Who cannot join
- Participants will be excluded if they:
- Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team
- Will undergo primary or palliative chemotherapy
- Are recommended to have chemoradiotherapy
- Are under 18 years old
- Are over 79 years old
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- Are unable to undergo CPEX testing
- Do not wish to take part in selected aspects of the study
- Cannot or do not wish to attend the CHHP for assessment and/or advice on exercise
- Cannot understand and give informed consent to the study
- Cannot understand and complete the questionnaires
- Do not wish to wear a Fitbit monitoring device
- ASA 4+
- Patients with BMI of less than 18.5 with self-reported unintentional weight loss of 10% or more at diagnosis.
Trial locations and contacts
1 site in 1 country.
Andrew Davies, MBChBMDFRCS contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas' Hospital
London, SE1 7EH
Janine Zylstra, janine.zylstra@gstt.nhs.uk
Andrew Davies, MBChBMDFRCS
About this study
Official title: 'Pre-EMPT' - An Interventional Study to Assess the Effects of Pre-emptive Exercise , or 'Prehabilitation', in Patients Undergoing Peri-operative Treatment for Adenocarcinoma of the Oesophagus and Gastro-oesophageal Junction
'Pre-EMPT' - A cohort-controlled, interventional study to assess the effects of a pre-emptive exercise programme, or 'prehabilitation', in patients undergoing peri-operative chemotherapy for adenocarcinoma of the lower oesophagus and gastro-oesophageal junction.
Read the detailed description
Oesophageal cancer has the fastest rising incidence of any solid tumour in the western world with the UK, and London, having particularly high rates of the disease.
Those patients being considered for "cure" will benefit from pre-operative/neo-adjuvant chemotherapy (NAC), which is known to have a deleterious effect on fitness and is associated with increased post-operative morbidity. Post-operative morbidity is also associated with reduced survival. Reduction in fitness is compounded by major surgery and significantly reduces the numbers of patients who commence or complete the standard treatment of post-operative chemotherapy to around 40%.
Chemotherapy and surgery for oesophageal cancer both represent significant physiological insults that may have detrimental effects on physical activity and outcomes after surgery. Cardiopulmonary exercise (CPEX) testing has been effectively used in numerous tumour groups to predict outcome after surgery, although its role in oesophageal cancer patients remains uncertain owing to conflicting data from institutional series. Advanced exercise programmes, sometimes termed 'prehabilitation', directed by experienced multidisciplinary teams are increasingly being used to mitigate the secondary effects of cancer treatment.
'Prehabilitation' has been shown to reduce postoperative morbidity and mortality in thoracic patients undergoing elective high-risk surgery. In addition, results of studies examining physical exercise and cancer recurrence/survival which effect immune system function in cancer survivors suggest that physical exercise training may improve a number of immune system parameters that may be important in cancer defence.
The investigators believe that optimising patient fitness through a structured and expert-devised exercise programme of 'prehabilitation' during neo-adjuvant chemotherapy and prior to surgery will mitigate the effects of chemotherapy and improve patient outcomes after surgery.
The investigators intend to assess the feasibility of a 'prehabilitation' programme and quantify the resultant effects primarily using CPEX testing. In addition, changes in hospital 'length of stay' will be documented with a number of additional parameters.
- Conditions
- Oesophageal Adenocarcinoma, Chemotherapy Effect, Surgery
- Being tested
- Exercise prehabilitation during chemotherapy before surgery
- Keywords
- Prehabilitation, Exercise, Cancer, Neo-adjuvant chemotherapy
- Medical subject headings
- Adenocarcinoma Of Esophagus, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise prehabilitation during chemotherapy before surgeryBehavioural
Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Participants will be given a monitored exercise program during their treatment starting before chemotherapy Receives: Behavioral: Exercise prehabilitation during chemotherapy before surgery |
| Non-interventional | No intervention | Patients will have standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary fitness
Cardiopulmonary exercise test on bicycle ergometer
Measured: Baseline to 5 months
Secondary outcomes (10)
Post-operative complications
Clavien-Dindo; ECCG- Esophageal Complications Consensus Group
Measured: Date of surgery to date of discharge, up to 45 days post-surgery
Post-operative length of hospital stay
Number of in-hospital days from date of surgery
Measured: Date of surgery to date of discharge, up to 45 days post-surgery
Lean body mass
Computerised tomography assessment of lean body mass
Measured: Baseline to 5 months
Daily activity levels
Steps per day measured by Fitbit
Measured: Baseline to 5 months
Sleep quality assessment
Sleep data from Fitbit
Measured: Baseline to 5 months
Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire
EORTC QLQ-OES18
Measured: Baseline to 12 months post-surgery
Change in Health-related Quality of Life: Cancer questionniare
EORTC QLQ-C30
Measured: Baseline to 12 months post-surgery
Change in Well-being
SWEMWEBS questionnaire
Measured: Baseline to 12 months post-surgery
Disease recurrence
Pathological or radiological confirmation of recurrent disease
Measured: Date of surgery to date of recurrence, up to 12 months post-surgery
Post-operative mortality
In-patient, 30-day, 90-day, 1-year
Measured: Date of surgery to date of death, up to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study startNov 2016
- Primary completionMay 2020 (estimated)
- Study completionJun 2021 (estimated)
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 Oesophageal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort-controlled
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Davies, MBChBMDFRCS, Principal investigator, Consultant Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626610
- Sponsor's protocol ID
- IRAS 204711 Pre-EMPT PROTOCOL
- Acronym
- Pre-EMPT
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zylstra J, Whyte GP, Beckmann K, Pate J, Santaolalla A, Gervais-Andre L, Russell B, Maisey N, Waters J, Tham G, Lagergren J, Green M, Kelly M, Baker C, Van Hemelrijck M, Goh V, Gossage J, Browning M, Davies A. Exercise prehabilitation during neoadjuvant chemotherapy may enhance tumour regression in oesophageal cancer: results from a prospective non-randomised trial. Br J Sports Med. 2022 Apr;56(7):402-409. doi: 10.1136/bjsports-2021-104243. Epub 2022 Feb 1.
PubMed 35105604
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Pre-EMPT' - An Interventional Study to Assess the Effects of Pre-emptive Exercise , or 'Prehabilitation', in Patients Undergoing Peri-operative Treatment for Adenocarcinoma of the Oesophagus and Gastro-oesophageal Junction
- ClinicalTrials.gov ID
- NCT03626610
- Acronym / sponsor ID
- Pre-EMPT / IRAS 204711 Pre-EMPT PROTOCOL
- Conditions
- Oesophageal Adenocarcinoma, Chemotherapy Effect, Surgery
- Keywords
- Prehabilitation, Exercise, Cancer, Neo-adjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Aug 2018 (actual)
- 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.
'Pre-EMPT' - A cohort-controlled, interventional study to assess the effects of a pre-emptive exercise programme, or 'prehabilitation', in patients undergoing peri-operative chemotherapy for adenocarcinoma of the lower oesophagus and gastro-oesophageal junction.
Detailed description
Oesophageal cancer has the fastest rising incidence of any solid tumour in the western world with the UK, and London, having particularly high rates of the disease.
Those patients being considered for "cure" will benefit from pre-operative/neo-adjuvant chemotherapy (NAC), which is known to have a deleterious effect on fitness and is associated with increased post-operative morbidity. Post-operative morbidity is also associated with reduced survival. Reduction in fitness is compounded by major surgery and significantly reduces the numbers of patients who commence or complete the standard treatment of post-operative chemotherapy to around 40%.
Chemotherapy and surgery for oesophageal cancer both represent significant physiological insults that may have detrimental effects on physical activity and outcomes after surgery. Cardiopulmonary exercise (CPEX) testing has been effectively used in numerous tumour groups to predict outcome after surgery, although its role in oesophageal cancer patients remains uncertain owing to conflicting data from institutional series. Advanced exercise programmes, sometimes termed 'prehabilitation', directed by experienced multidisciplinary teams are increasingly being used to mitigate the secondary effects of cancer treatment.
'Prehabilitation' has been shown to reduce postoperative morbidity and mortality in thoracic patients undergoing elective high-risk surgery. In addition, results of studies examining physical exercise and cancer recurrence/survival which effect immune system function in cancer survivors suggest that physical exercise training may improve a number of immune system parameters that may be important in cancer defence.
The investigators believe that optimising patient fitness through a structured and expert-devised exercise programme of 'prehabilitation' during neo-adjuvant chemotherapy and prior to surgery will mitigate the effects of chemotherapy and improve patient outcomes after surgery.
The investigators intend to assess the feasibility of a 'prehabilitation' programme and quantify the resultant effects primarily using CPEX testing. In addition, changes in hospital 'length of stay' will be documented with a number of additional parameters.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Cohort-controlled
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Behavioral: Exercise prehabilitation during chemotherapy before surgeryParticipants will be given a monitored exercise program during their treatment starting before chemotherapy |
| Non-interventional | No intervention | –Patients will have standard care. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must be diagnosed with operable oesophageal and gastro-oesophageal adenocarcinoma and scheduled to undergo standard neo-adjuvant chemotherapy and oesophago-gastric surgery as recommended by the Multidisciplinary Meeting decision.
- 18+
- </=79 (patients above this age may be included in studies after the feasibility study has been completed)
- Participants must be able to understand and independently consent to participation in the study.
- Participants must be able to understand and complete the questionnaires.
Key exclusion criteria (14 listed)
- Are not considered medically fit for surgery at diagnosis, as decided by the Multidisciplinary team
- Will undergo primary or palliative chemotherapy
- Are recommended to have chemoradiotherapy
- Are under 18 years old
- Are over 79 years old
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 |
|---|---|---|
| Exercise prehabilitation during chemotherapy before surgeryMonitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma | Behavioural | Interventional |
Primary outcome
Cardiopulmonary fitness
Time frame: Baseline to 5 months
Cardiopulmonary exercise test on bicycle ergometer
10 secondary outcomes
Post-operative complications
Time frame: Date of surgery to date of discharge, up to 45 days post-surgery
Post-operative length of hospital stay
Time frame: Date of surgery to date of discharge, up to 45 days post-surgery
Lean body mass
Time frame: Baseline to 5 months
Daily activity levels
Time frame: Baseline to 5 months
Sleep quality assessment
Time frame: Baseline to 5 months
Change in Health-related Quality of Life: Oesophageal cancer-specific questionnaire
Time frame: Baseline to 12 months post-surgery
Change in Health-related Quality of Life: Cancer questionniare
Time frame: Baseline to 12 months post-surgery
Change in Well-being
Time frame: Baseline to 12 months post-surgery
Disease recurrence
Time frame: Date of surgery to date of recurrence, up to 12 months post-surgery
Post-operative mortality
Time frame: Date of surgery to date of death, up to 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 35105604Zylstra J, Whyte GP, Beckmann K, Pate J, Santaolalla A, Gervais-Andre L, Russell B, Maisey N, Waters J, Tham G, Lagergren J, Green M, Kelly M, Baker C, Van Hemelrijck M, Goh V, Gossage J, Browning M, Davies A. Exercise prehabilitation during neoadjuvant chemotherapy may enhance tumour regression in oesophageal cancer: results from a prospective non-randomised trial. Br J Sports Med. 2022 Apr;56(7):402-409. doi: 10.1136/bjsports-2021-104243. Epub 2022 Feb 1.
- Individual participant dataSharing planned: Undecided
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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.
Andrew Davies, MBChBMDFRCS contact
Andrew Davies, MBChBMDFRCS principal investigator
Consultant Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise prehabilitation during chemotherapy before surgery in people with Oesophageal Adenocarcinoma and Chemotherapy Effect, run by Guy's and St Thomas' 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 13 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janine Zylstra (+44 (0) 20 7188 7188 ext. 52786, janine.zylstra@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary fitness (time frame: Baseline to 5 months). 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 NCT03626610, 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 13 Aug 2018.