Clinical trial NCT06310993: Exercise to Boost Immunity in Advanced Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mesothelioma; Lung
Pancreatic Cancer
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Hallam University
name: University of Sheffield
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome Measure
timeFrame: completion of the 12-week exercise intervention
Secondary outcomes:
measure: Secondary outcome 1
timeFrame: completion of the 12-week exercise intervention
measure: Secondary Outcome 2
timeFrame: completion of the 12-week exercise intervention
measure: Secondary Outcome 3
timeFrame: completion of the 12-week exercise intervention
measure: Secondary Outcome 4
timeFrame: Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention
measure: Secondary Outcome 5
timeFrame: Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention.
measure: Secondary Outcome 6
timeFrame: Baseline and at 12 weeks
measure: Secondary Outcome 7
timeFrame: Baseline and at 12 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Cancer Research Centre at Weston Park Hospital
state: England
city: Sheffield
country: United Kingdom
facility: Sheffield Hallam University
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS FT
name: Brindley Hapuarachi, MD
role: PRINCIPAL_INVESTIGATOR
References: