Will a Pre-therapy Exercise Intervention Improve the Outcomes of Patients With Advanced Oesophageal Cancer?

NCT07375420 | Recruiting

• 1 other identifier: 326527
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

T Cells; Oesophageal Adenocarcinoma; Tumor Microenvironment; Exercise

Keywords

oesophageal cancer; exercise; tumour microenvironment

Outcome Measures

Primary Outcomes (2)

• Tumour immune infiltration

  Percentage increase of CD8 T Cells within the tumour

  From enrollment to the end of treatment at 16 weeks

• Improvement in cardiorespiratory function

  Measured through VO2 peak

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (2)

• Change in peripheral blood mononuclear cells (PBMC)

  From enrollment to the end of treatment at 16 weeks

• Change in plasma cytokines

  From enrollment to the end of treatment at 16 weeks

Study Arms (2)

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

Interventions

Low intensity exercise BEHAVIORAL

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.

Low intensity/Low amount (LAM) arm

High intensity exercise BEHAVIORAL

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).

moderate-vigorous-intensity/moderate-high-amount (MAM) arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with resectable oesophageal adenocarcinoma who are planned for neoadjuvant chemotherapy followed by surgery

You may not qualify if:

• Inability to carry out CPET or exercise due to underlying health conditions
• pregnancy
• \<18 years old

Sponsors & Collaborators

• University of Surrey: lead
• World Cancer Research Fund International: collaborator

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Motor Activity; Esophageal Neoplasms

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Adam Frampton, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamal Dirie, MD

CONTACT

+447944688517; jd01928@surrey.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Adam Frampton

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: April 26, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)