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| Name | Class |
|---|---|
| Sheffield Hallam University | OTHER |
| University of Sheffield | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | Exercise programme is the intervention for this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcome 1 | The number of directly related adverse events. | completion of the 12-week exercise intervention |
| Secondary Outcome 2 | Acceptability rate: the ratio of those recruited to the trial to those approached as eligible. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brindley Hapuarachi, MD | Contact | 07809741940 | sbhapuarachchi1@sheffield.ac.uk | |
| Grace Cole | Contact | sth.researchadministration@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Brindley Hapuarachi, MD | Sheffield Teaching Hospitals NHS FT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research Centre at Weston Park Hospital | Sheffield | England | S1O 2SJ | United Kingdom | ||
| Sheffield Hallam University |
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| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| completion of the 12-week exercise intervention |
| Secondary Outcome 3 | Attrition rate: the ratio of dropouts from the trial to those enrolled initially. | completion of the 12-week exercise intervention |
| 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 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 Outcome 6 | Evidence of radiological response or progression as per RECIST 1.1 reporting of CT scans | Baseline and at 12 weeks |
| Secondary Outcome 7 | Lung function as per results of lung function tests | Baseline and at 12 weeks |
| Sheffield |
| South Yorkshire |
| S10 2BP |
| United Kingdom |
| D018301 |
| Neoplasms, Mesothelial |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |