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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Sheffield
Sheffield Hallam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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