From the blog

Exercise to Boost Immunity in Advanced Cancer (BICEP)

Published: March 15, 2024

Primary Outcome Measures

Outcome Measure Measure Description Time Frame
Primary Outcome Measure Adherence rate: The ratio of the number of exercise sessions performed to the number of exercise sessions planned. completion of the 12-week exercise intervention

 

Secondary Outcome Measures

Outcome Measure Measure Description Time Frame
Secondary outcome 1 The number of directly related adverse events. completion of the 12-week exercise intervention
Secondary Outcome 2 Acceptability rate: the ratio of those recruited to the trial to those approached as eligible. completion of the 12-week exercise intervention
Secondary Outcome 3 Attrition rate: the ratio of dropouts from the trial to those enrolled initially. completion of the 12-week exercise intervention
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). Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention
Secondary Outcome 5 The levels of cytokines/ myokines in the blood Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention.
Secondary Outcome 6 Evidence of radiological response or progression as per RECIST 1.1 reporting of CT scans Baseline and at 12 weeks
Secondary Outcome 7 Lung function as per results of lung function tests Baseline and at 12 weeks

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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