Exercise to Boost Immunity in Advanced Cancer (BICEP)

March 15, 2024

Primary Outcome Measures

Adherence rate: The ratio of the number of exercise sessions performed to the number of exercise sessions planned.

Secondary Outcome Measures

The number of directly related adverse events.
Acceptability rate: the ratio of those recruited to the trial to those approached as eligible.
Attrition rate: the ratio of dropouts from the trial to those enrolled initially.
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).
The levels of cytokines/ myokines in the blood
Evidence of radiological response or progression as per RECIST 1.1 reporting of CT scans
Lung function as per results of lung function tests

Inclusion Criteria

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)
Ability to provide informed consent

Exclusion Criteria

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.
Patients who have progressed on first line palliative chemotherapy for advanced, unresectable, or metastatic pancreatic cancer.
Patients with active co-morbidities that would prevent or limit their participation in the exercise intervention
Age below 18 years old
No histological or cytological diagnosis of mesothelioma or pancreatic cancer.
ECOG Performance status of 2 or more
Unable to provide informed consent

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