Oesophageal AdenocarcinomaOPTIMUSNCT07375420
Will a Pre-therapy Exercise Intervention Improve the Outcomes of Patients With Advanced Oesophageal Cancer?
A study testing Low intensity exercise and High intensity exercise in people with Oesophageal Adenocarcinoma and T Cells, run by University of Surrey at 1 site in United Kingdom.
Trial summary
Background Regular exercise can significantly improve physical and mental health during cancer treatment and reduce the time needed in the hospital. Animal studies suggest that exercise training can also reduce the number of cancer cells. For example, exercise training in mice produces more immune cells in the tumour. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oesophageal Adenocarcinoma, T Cells, Tumor Microenvironment
- What is being tested?
- Low intensity exercise and High intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2024to 30 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with resectable oesophageal adenocarcinoma who are planned for neoadjuvant chemotherapy followed by surgery
Who cannot join
- Inability to carry out CPET or exercise due to underlying health conditions
- pregnancy
- <18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Surrey
Guildford, Surrey, GU2 7XH
Jamal Dirie, MD, +446944688517, jd01928@surrey.ac.uk
Jamal Dirie, MD
About this study
Official title: Optimising Prehabilitation Exercise to Enhance Tumour Outcomes in Advanced Oesophageal Cancer
Background
Regular exercise can significantly improve physical and mental health during cancer treatment and reduce the time needed in the hospital. Animal studies suggest that exercise training can also reduce the number of cancer cells. For example, exercise training in mice produces more immune cells in the tumour. These immune cells in the tumour contribute to the destruction and reduction of the size of the tumour and are a vital component of effective immunotherapy (cancer treatment that helps the immune system fight cancer).
Read more
In humans, exercise training and the immune response in tumours are less understood. Only 1 study has investigated the effect of a single exercise session before surgical removal of the prostate in prostate cancer patients. As the benefits of exercise are gained from weeks/months of exercise, no effect on the immune cells in the tumours were found.
The investigators have carried out a previous study looking at how exercise affects fitness before major surgery. After this they used state-of-the-art methods to detect and visualise immune cells within the tumour. Compared with the patients who did not exercise, the exercise group had significantly more immune cells in their tumours, consisting of a group of cells that are important for killing cancerous cells called CD8+ T cells. CD8+ T cells in tumours are associated with improved survival outcomes.
Importantly, they found a link between changes in fitness and the amount of these cells in the tumour. This suggests that if there is increase in fitness, there also an increase in the frequency of these cells in the tumour. Therefore, the investigators propose performing a clinical trial to find out the best level of exercise patients need to sustain before surgery to produce this improved immune response.
The trial will aim to understand how this happens and how the entry of immune cells into the tumour changes the environment around a tumour. The investigators consist of a team of exercise immunologists, tumour immunologists and clinicians working with the Human Performance Institute at the University of Surrey in collaboration with the Royal Surrey NHS Trust.
How it will be done
The investigators will assess immune cell response in blood samples obtained from oesophageal cancer patients before, during and after a high or low intensity exercise programme. Following the exercise programme, tumour tissue removed at surgery from these patients will be used to investigate the the presence and quantity of these immune cells.
Potential impact
A better understanding of this is important, as current anti-cancer immune-based therapeutics work best when there is a an immune response within the patient's tumour. Generating evidence that exercise can improve the immune response against the tumour in patients with oesophageal cancer would provide significant justification for introducing "personalised" exercise programmes to improve treatment outcomes.
Read the detailed description
Oesophageal cancer is one of the most challenging cancers to treat, with low survival rates, even when people receive intensive treatments such as chemotherapy and surgery. New treatment strategies could therefore lead to significant benefits to patients.
One of the most promising new treatments is immunotherapy, which works by "releasing the brakes" on immune cells. Immunotherapy has transformed outcomes in some cancers, but its impact in oesophageal cancer has been modest so far. One important reason may be that many oesophageal tumours contain few active immune cells to begin with. Finding safe, practical ways to ''wake up'' the immune system and draw immune cells into the tumour could make existing treatments more effective.
Exercise is a simple, low-cost option that could help. Exercise programmes are already used before major surgery to improve fitness and help people cope better with treatment. Research in other cancers shows that exercise can increase the number and activity of key immune cells in the blood and, in some cases, inside tumours. Exercise also affects the gut microbiome. This is the community of bacteria and other microorganisms in our intestines, and the chemicals they produce. These microbial products can travel through the bloodstream and shape how the immune system behaves. However, it is still unclear yhow these changes work together in people with oesophageal cancer receiving chemotherapy.
In this study, people with oesophageal cancer who are due to receive chemotherapy before surgery will be invited to join a supervised exercise programme. All patients will exercise under the guidance of specialist staff while they are on chemotherapy. One group will follow a lower-intensity programme similar to current NHS prehabilitation. The other group will complete higher-intensity sessions, within safe limits. Comparing these two realistic options will allow us to test whether exercise intensity makes a difference.
The investigators will collect blood and stool samples at key time points before and during treatment. From blood, there will be an analysis of the changes in immune cells and proteins that signal how "switched on" the immune system is. From stool, the investigators will study the gut microbiome and the metabolites (small molecules) they produce. After surgery, the removed tumour will be examined under the microscope to see whether exercise is linked to differences in the number and type of immune cells inside the tumour. By bringing these measurements together, we hope to understand whether more intensive exercise leads to a more immune-active tumour, and how the change in immune cells alongside systemic signalling molecules are related to these states.
- Conditions
- Oesophageal Adenocarcinoma, T Cells, Tumor Microenvironment, Exercise
- Being tested
- Low intensity exercise, High intensity exercise
- Keywords
- oesophageal cancer, exercise, tumour microenvironment
- Medical subject headings
- Adenocarcinoma Of Esophagus, Motor Activity, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity exerciseBehavioural
Participants undertake supervised cycling twice weekly. Each session comprises 5 min warm-up at 30% heart rate reserve (HRR), then 20 min continuous cycling starting at 40% HRR. After participants complete two supervised sessions/week at 40% HRR without adverse events, intensity increases by 5% HRR per session to a target of 60% HRR, which is maintained for the remainder of the pre-operative period (until surgery). After cycling, participants complete flexibility and resistance exercises targeting six major muscle groups (2 sets of 12 repetitions, rating of perceived exertion (RPE) 12-14), with load increased when RPE <12. Participants also complete a home programme three times weekly (60 min/session) focusing on resistance and core stability using appropriately weighted bands.
High intensity exerciseBehavioural
Exercise Group 2 (moderate-vigorous-intensity/moderate-high-amount (MAM)) is a progressive, individualised programme with two supervised aerobic sessions/week using harness-supported treadmill walking where possible, or cycle ergometry if needed. Each session begins with 5 min at 40% heart rate reserve (HRR). For ~2 weeks, participants complete 15 min of intervals (30 s at 80% HRR then 1 min at 50% HRR), followed by 5 min cool-down at 40% HRR. Training then progresses by increasing hard bouts to 1 min, building to 20 intervals, then targeting 90%/50% HRR with gradual increases in time spent at 90% HRR. After aerobic exercise, flexibility plus resistance (chest press, leg press, seated row) is performed for 2 sets to fatigue at rating of perceived exertion (RPE) 15-17, increasing load when 2x25 reps are achieved. Home aerobic exercise is prescribed for 60 min, 3x/week at ~60% HRR using heart-rate telemetry (home cycle provided if walking not feasible).
| Study group | Role | What they receive |
|---|---|---|
| Low intensity/Low amount (LAM) arm | Active comparator | Not described Receives: Behavioral: Low intensity exercise |
| moderate-vigorous-intensity/moderate-high-amount (MAM) arm | Experimental | Not described Receives: Behavioral: High intensity exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour immune infiltration
Percentage increase of CD8 T Cells within the tumour
Measured: From enrollment to the end of treatment at 16 weeks
Improvement in cardiorespiratory function
Measured through VO2 peak
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (2)
Change in peripheral blood mononuclear cells (PBMC)
We will analyse longitudinal shifts in PBMC subsets and phenotypes.
Measured: From enrollment to the end of treatment at 16 weeks
Change in plasma cytokines
We will analyse longitudinal shifts in PBMC subsets and phenotypes.
Measured: From enrollment to the end of treatment at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start26 Apr 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- World Cancer Research Fund International
- Responsible party
- Principal investigator, Adam Frampton, University of Surrey
- Investigators
- Adam Frampton, PhD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375420
- Sponsor's protocol ID
- 326527
- Acronym
- OPTIMUS
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Prehabilitation Exercise to Enhance Tumour Outcomes in Advanced Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT07375420
- Acronym / sponsor ID
- OPTIMUS / 326527
- Conditions
- Oesophageal Adenocarcinoma, T Cells, Tumor Microenvironment, Exercise
- Keywords
- oesophageal cancer, exercise, tumour microenvironment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- World Cancer Research Fund International
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
Background
Regular exercise can significantly improve physical and mental health during cancer treatment and reduce the time needed in the hospital. Animal studies suggest that exercise training can also reduce the number of cancer cells. For example, exercise training in mice produces more immune cells in the tumour. These immune cells in the tumour contribute to the destruction and reduction of the size of the tumour and are a vital component of effective immunotherapy (cancer treatment that helps the immune system fight cancer).
In humans, exercise training and the immune response in tumours are less understood. Only 1 study has investigated the effect of a single exercise session before surgical removal of the prostate in prostate cancer patients. As the benefits of exercise are gained from weeks/months of exercise, no effect on the immune cells in the tumours were found.
The investigators have carried out a previous study looking at how exercise affects fitness before major surgery. After this they used state-of-the-art methods to detect and visualise immune cells within the tumour. Compared with the patients who did not exercise, the exercise group had significantly more immune cells in their tumours, consisting of a group of cells that are important for killing cancerous cells called CD8+ T cells. CD8+ T cells in tumours are associated with improved survival outcomes.
Importantly, they found a link between changes in fitness and the amount of these cells in the tumour. This suggests that if there is increase in fitness, there also an increase in the frequency of these cells in the tumour. Therefore, the investigators propose performing a clinical trial to find out the best level of exercise patients need to sustain before surgery to produce this improved immune response.
The trial will aim to understand how this happens and how the entry of immune cells into the tumour changes the environment around a tumour. The investigators consist of a team of exercise immunologists, tumour immunologists and clinicians working with the Human Performance Institute at the University of Surrey in collaboration with the Royal Surrey NHS Trust.
How it will be done
The investigators will assess immune cell response in blood samples obtained from oesophageal cancer patients before, during and after a high or low intensity exercise programme. Following the exercise programme, tumour tissue removed at surgery from these patients will be used to investigate the the presence and quantity of these immune cells.
Potential impact
A better understanding of this is important, as current anti-cancer immune-based therapeutics work best when there is a an immune response within the patient's tumour. Generating evidence that exercise can improve the immune response against the tumour in patients with oesophageal cancer would provide significant justification for introducing "personalised" exercise programmes to improve treatment outcomes.
Detailed description
Oesophageal cancer is one of the most challenging cancers to treat, with low survival rates, even when people receive intensive treatments such as chemotherapy and surgery. New treatment strategies could therefore lead to significant benefits to patients.
One of the most promising new treatments is immunotherapy, which works by "releasing the brakes" on immune cells. Immunotherapy has transformed outcomes in some cancers, but its impact in oesophageal cancer has been modest so far. One important reason may be that many oesophageal tumours contain few active immune cells to begin with. Finding safe, practical ways to ''wake up'' the immune system and draw immune cells into the tumour could make existing treatments more effective.
Exercise is a simple, low-cost option that could help. Exercise programmes are already used before major surgery to improve fitness and help people cope better with treatment. Research in other cancers shows that exercise can increase the number and activity of key immune cells in the blood and, in some cases, inside tumours. Exercise also affects the gut microbiome. This is the community of bacteria and other microorganisms in our intestines, and the chemicals they produce. These microbial products can travel through the bloodstream and shape how the immune system behaves. However, it is still unclear yhow these changes work together in people with oesophageal cancer receiving chemotherapy.
In this study, people with oesophageal cancer who are due to receive chemotherapy before surgery will be invited to join a supervised exercise programme. All patients will exercise under the guidance of specialist staff while they are on chemotherapy. One group will follow a lower-intensity programme similar to current NHS prehabilitation. The other group will complete higher-intensity sessions, within safe limits. Comparing these two realistic options will allow us to test whether exercise intensity makes a difference.
The investigators will collect blood and stool samples at key time points before and during treatment. From blood, there will be an analysis of the changes in immune cells and proteins that signal how "switched on" the immune system is. From stool, the investigators will study the gut microbiome and the metabolites (small molecules) they produce. After surgery, the removed tumour will be examined under the microscope to see whether exercise is linked to differences in the number and type of immune cells inside the tumour. By bringing these measurements together, we hope to understand whether more intensive exercise leads to a more immune-active tumour, and how the change in immune cells alongside systemic signalling molecules are related to these states.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity/Low amount (LAM) arm | Active comparator | Behavioral: Low intensity exercise |
| moderate-vigorous-intensity/moderate-high-amount (MAM) arm | Experimental | Behavioral: High intensity exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with resectable oesophageal adenocarcinoma who are planned for neoadjuvant chemotherapy followed by surgery
Key exclusion criteria (3 listed)
- Inability to carry out CPET or exercise due to underlying health conditions
- pregnancy
- <18 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 |
|---|---|---|
| Low intensity exerciseParticipants undertake supervised cycling twice weekly. Each session comprises 5 min warm-up at 30% heart rate reserve (HRR), then 20 min continuous cycling starting at 40% HRR. After participants complete two supervised sessions/week at 40% HRR without adverse events, intensity increases by 5% HRR per session to a target of 60% HRR, which is maintained for the remainder of the pre-operative period (until surgery). After cycling, participants complete flexibility and resistance exercises targeting six major muscle groups (2 sets of 12 repetitions, rating of perceived exertion (RPE) 12-14), with load increased when RPE <12. Participants also complete a home programme three times weekly (60 min/session) focusing on resistance and core stability using appropriately weighted bands. | Behavioural | Low intensity/Low amount (LAM) arm |
| High intensity exerciseExercise Group 2 (moderate-vigorous-intensity/moderate-high-amount (MAM)) is a progressive, individualised programme with two supervised aerobic sessions/week using harness-supported treadmill walking where possible, or cycle ergometry if needed. Each session begins with 5 min at 40% heart rate reserve (HRR). For ~2 weeks, participants complete 15 min of intervals (30 s at 80% HRR then 1 min at 50% HRR), followed by 5 min cool-down at 40% HRR. Training then progresses by increasing hard bouts to 1 min, building to 20 intervals, then targeting 90%/50% HRR with gradual increases in time spent at 90% HRR. After aerobic exercise, flexibility plus resistance (chest press, leg press, seated row) is performed for 2 sets to fatigue at rating of perceived exertion (RPE) 15-17, increasing load when 2x25 reps are achieved. Home aerobic exercise is prescribed for 60 min, 3x/week at ~60% HRR using heart-rate telemetry (home cycle provided if walking not feasible). | Behavioural | moderate-vigorous-intensity/moderate-high-amount (MAM) arm |
Primary outcome
Tumour immune infiltration
Time frame: From enrollment to the end of treatment at 16 weeks
Percentage increase of CD8 T Cells within the tumour
Improvement in cardiorespiratory function
Time frame: From enrollment to the end of treatment at 16 weeks
Measured through VO2 peak
2 secondary outcomes
Change in peripheral blood mononuclear cells (PBMC)
Time frame: From enrollment to the end of treatment at 16 weeks
Change in plasma cytokines
Time frame: From enrollment to the end of treatment at 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes
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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.
Adam Frampton, PhD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity exercise and High intensity exercise in people with Oesophageal Adenocarcinoma and T Cells, run by University of Surrey 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 3 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: looking for participants now, as of the sponsor's last update on 2 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamal Dirie, MD (+447944688517, jd01928@surrey.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour immune infiltration (time frame: From enrollment to the end of treatment at 16 weeks). The study lists 2 primary outcomes in all. 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 2 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.