Exercise to Boost Immunity in Advanced Cancer

Pancreatic Cancer Clinical Trial

— BICEP  

Official title:

Exercise to Boost Immunity in Advanced Cancer: Feasibility of Combined Aerobic Exercise and Resistance Training for Patients With Advanced Mesothelioma and Pancreatic Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06310993
• Other study ID #: STH22549
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: Brindley Hapuarachi, MD
• Phone: 07809741940
• Email: sbhapuarachchi1[@]sheffield.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Immunotherapy is rapidly revolutionising cancer care with ICIs demonstrating clinical efficacy in multiple cancer settings and are indicated in the peri-operative, advanced, and recurrent settings for various tumour types. Mesothelioma is classed as a "hot tumour" due to its lymphocyte rich tumour microenvironment which has demonstrated some clinical response to immunotherapy. On the other end of the spectrum, 'cold tumours' such as pancreatic cancer, have been shown to have low immune cell populations and reduced immune activity within their tumour microenvironments. Evidence suggests that in cancer patients, exercise improves overall health, may prolong survival as well as reduce cancer-related fatigue and modulate the immune system through multiple mechanisms. Physical activity is defined as 'any bodily movement produced by skeletal muscles or that requires contraction of your muscles and energy expenditure. Exercise-induced leucocytosis refers to the immediate increase in circulatory leukocytes after a single exercise activity. The use of exercise as medicine requires an understanding of the appropriate dose which is highly dependent on the FITT principles (Frequency, Intensity, Time, and Type) and this is crucial for generating desired outcomes. Although ICIs have revolutionised treatment for many different cancers, less than 40% of patients derive significant benefit from ICIs which highlights the need to improve responsiveness The primary objective is to determine the feasibility of exercise during systemic anti-cancer treatment in patients with advanced mesothelioma or pancreatic cancer.

The secondary objectives are:

iTo determine the safety of exercise during systemic anti-cancer treatment in patients with advanced mesothelioma or pancreatic cancer.

ii. To determine the acceptability of exercise during systemic anti-cancer treatment in patients with advanced mesothelioma or pancreatic cancer.

iii. Does exercise boost immune cell activation in cancer patients? iv. To determine the effect of exercise on cytokine/ myokine levels in the blood v.To determine the effect of exercise on radiological response or progression. vi.To determine the effect of exercise on lung function.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesothelioma
• Mesothelioma, Malignant
• Mesothelioma; Lung
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Exercise
Exercise programme is the intervention for this study

Locations

Country	Name	City	State
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Sheffield Hallam University	Sheffield	South Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield Hallam University, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary outcome 1	The number of directly related adverse events.	completion of the 12-week exercise intervention
Secondary	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	Secondary Outcome 3	Attrition rate: the ratio of dropouts from the trial to those enrolled initially.	completion of the 12-week exercise intervention
Secondary	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	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	Secondary Outcome 6	Evidence of radiological response or progression as per RECIST 1.1 reporting of CT scans	Baseline and at 12 weeks
Secondary	Secondary Outcome 7	Lung function as per results of lung function tests	Baseline and at 12 weeks