Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310993
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-28
Brief Title:
Exercise to Boost Immunity in Advanced Cancer
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BICEP
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 vTo determine the effect of exercise on radiological response or progression viTo determine the effect of exercise on lung function
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 vTo determine the effect of exercise on radiological response or progression viTo determine the effect of exercise on lung function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None