Exercise to Boost Immunity in Advanced Cancer

NCT06310993 | Not Yet Recruiting

• 1 other identifier: STH22549
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Mesothelioma; Lung; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Secondary outcome 1

  completion of the 12-week exercise intervention

• Secondary Outcome 2

  completion of the 12-week exercise intervention

• Secondary Outcome 3

  completion of the 12-week exercise intervention

• Secondary Outcome 4

  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

  Baseline, then 4-weekly pre- and post- exercise interventions for 12 weeks and then at completion of the 12-week exercise intervention.

Study Arms (1)

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

Other: Exercise

Interventions

Exercise OTHER

Exercise programme is the intervention for this study

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Sheffield Hallam University: collaborator
• University of Sheffield: collaborator

Study Sites (2)

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BP, United Kingdom

Location

MeSH Terms

Conditions

Mesothelioma; Pancreatic Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brindley Hapuarachi, MD

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brindley Hapuarachi, MD

CONTACT

07809741940; sbhapuarachchi1@sheffield.ac.uk

Grace Cole

CONTACT

sth.researchadministration@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 15, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)