Exercise to Boost Immunity in Advanced Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheffield Teaching Hospitals NHS Foundation Trust
About this trial
The trial is a prospective feasibility trial conducted in Sheffield. Recruitment will include twenty patients receiving first line palliative immunotherapy for advanced, unresectable or metastatic mesothelioma and patients receiving first line systemic anti-cancer treatment for pancreatic cancer. Patients will attend the AWRC for a supervised exercise session once a week to include aerobic exercise along with an unsupervised weekly exercise session for 3 months. Blood samples will be collected at baseline and then monthly for 3 months, pre and post the supervised exercise session. Cytokine, myokine and immune cell concentration will be analysed using cytokine bead-based multiplex immune assays and RNA-seq to full profile changes in gene and protein expression
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients about to start or who are undergoing first line palliative immunotherapy for advanced, unresectable, or metastatic mesothelioma or patients about to start or who are undergoing first line palliative chemotherapy for advanced, unresectable, or metastatic pancreatic cancer.
Age over 18 years old
Histological or cytological diagnosis of mesothelioma or pancreatic cancer.
ECOG Performance status 0-1 (to be assessed by clinician)
Disqualifiers
Prior treatment with systemic anti-cancer treatment
More than one primary cancer
Uncontrolled brain or bone metastases
Patients who have progressed on first line palliative immunotherapy for advanced, unresectable, or metastatic mesothelioma.
Trial design
Design model
Single group
Treatments tested in this trial
Exercise
Other interventionExercise programme is the intervention for this study
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
Adherence rate: The ratio of the number of exercise sessions performed to the number of exercise sessions planned.
Time frame
completion of the 12-week exercise interventionSecondary outcomes
1
Secondary outcome 1
The number of directly related adverse events.
Time frame
completion of the 12-week exercise intervention2
Secondary Outcome 2
Acceptability rate: the ratio of those recruited to the trial to those approached as eligible.
Time frame
completion of the 12-week exercise intervention3
Secondary Outcome 3
Attrition rate: the ratio of dropouts from the trial to those enrolled initially.
Time frame
completion of the 12-week exercise intervention4
Secondary Outcome 4
Peripheral blood mononuclear cells (PBMC) in the blood. Immune cell activation will be determined by an increased in cytotoxic immune components (Natural Killer cells / CD8 T cells) and a decrease in immunosuppressive immune cells (regulatory T cells).
Time frame
Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
Sheffield Hallam University
Collaborator
University of Sheffield
Collaborator
Source ClinicalTrials.gov
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