Exercise to Boost Immunity in Advanced Cancer (BICEP)

November 27, 2024 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • England
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2BP
        • Sheffield Hallam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The exercise programme will include one weekly supervised exercise sessions and one weekly unsupervised exercise session. The frequency will be twice weekly, one supervised and one unsupervised session a week for 12 weeks. The exercises will be of moderate intensity aerobic interval exercise (performing at 60% maximum heart rate) combined with 1-3 sets of 6-12 Repetition Maximum (RM) resistance training. The type of exercise will be aerobic interval exercise (cycling) and Resistance training (3 exercises: chest press, biceps, and leg curl) The timing will be 4 x 4-minute cycling at 60%, max HR with 3 minutes active recovery. 3 sets with 2 minutes per set - around 20 minutes resistance training
Other: Exercise
Exercise programme is the intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Outcome Measure
Time Frame: completion of the 12-week exercise intervention
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
Time Frame: completion of the 12-week exercise intervention
The number of directly related adverse events.
completion of the 12-week exercise intervention
Secondary Outcome 2
Time Frame: completion of the 12-week exercise intervention
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
Time Frame: completion of the 12-week exercise intervention
Attrition rate: the ratio of dropouts from the trial to those enrolled initially.
completion of the 12-week exercise intervention
Secondary Outcome 4
Time Frame: Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention
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
Time Frame: Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention.
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
Time Frame: Baseline and at 12 weeks
Evidence of radiological response or progression as per RECIST 1.1 reporting of CT scans
Baseline and at 12 weeks
Secondary Outcome 7
Time Frame: Baseline and at 12 weeks
Lung function as per results of lung function tests
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

University of Sheffield
Sheffield Hallam University

Investigators

  • Principal Investigator: Brindley Hapuarachi, MD, Sheffield Teaching Hospitals NHS FT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH22549

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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