Sarcopenia and Physiology Assessments in Cancer Patients

NCT03641118 | Unknown

• 2 other identifiers: 16/SS/0188215694
• Study Type: observational
• Target: 639
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Aim: To establish a reliable relationship between oxygen uptake (VO2) at estimated lactate threshold (AT) and CT-derived body composition measurments (e.g. muscle radiation attenuation), and to relate these to post-operative outcomes (i.e. post-operative complications or 1-year survival) in cohort of upper (UGI) and lower (LGI) gastrointestinal and hepatobiliary (HPB) cancer patients undergoing surgery +/- cancer therapies. Rationale:Objectively measured reduction of muscle radiation attenuation (i.e. Computed Tomography (CT) measured indices of muscle wasting) coupled with reduced physical fitness (measured objectively using Cardiopulmonary Exercise Testing (CPET)) will result in worse post-operative surgical outcome and reduced survival. Trial Design: Observational Sample size: See statistical analyses section for individual cohort power calculations Inclusion Criteria: Male or female patients, aged over 18 years old with UGI, LGI or HPB cancer undergoing surgery +/- cancer therapies; WHO performance status 0-2. Exclusion Criteria: Patients will be excluded if they have surgery for benign disease, a diagnosis of inflammatory bowel disease, patients physically unable to perform a CPET on a cycle ergometer, patients having no surgery performed or interim emergency surgery, patients lacking complete in-hospital morbidity and survival data. Primary Trial Endpoints: UGI patients - 2 year overall survival, LGI and HPB patients - post-operative complications (Calvien-Dindo and Composite Endpoint in pancreaticoduodenectomy)

Conditions

Upper Gastrointestinal Disorders; Lower Gastrointestinal Disorders; Hepatobiliary Cancer

Keywords

cancer; sarcopenia; surgery; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle radiation attenuation at L3

  muscle radiation attenuation using CT L3 image slice using Slico-matic software

  up to 4 week before surgery

Secondary Outcomes (3)

• Surgical morbidity

  throughout study completion whilst patient is in hospital, up to 6 months

• Survival

  at 1 year after surgery

• oxygen uptake at lactate threshold

  up to 4 weeks before surgery

Study Arms (3)

Lower gastrointestinal cancer

All lower gastrointestinal neoplasms including rectal

Diagnostic Test: Cardiopulmonary exercise test

Upper gastrointestinal cancer

All upper gastrointestinal neoplasms

Diagnostic Test: Cardiopulmonary exercise test

Hepatobiliary cancers

All liver, pancreas, biliary cancer

Diagnostic Test: Cardiopulmonary exercise test

Interventions

Cardiopulmonary exercise test DIAGNOSTIC_TEST

The CPET test involves cycling on an exercise bike for 8-12 minutes. Starting with a very low resistance on the pedals the patient will pedal at 60 revolutions per minute. After 3 minutes of cycling, the resistance will gradually increase until the patient can no longer turn the pedals at the required speed. The test will be thoroughly explained to the patient beforehand and trained staff will make the experience as comfortable as possible. CPETs will be stopped early by the study researcher/doctor in the presence of any adverse events. Each CPET appointment will last approximately one hour.

Hepatobiliary cancers; Lower gastrointestinal cancer; Upper gastrointestinal cancer

Eligibility Criteria

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

Study Population

Upper gastrointestinal cancer, lower gastrointestinal cancer or hepatobiliary cancers

You may qualify if:

• Male or female patients
• aged over 18 years old
• undergoing surgery and/or cancer therapies
• WHO performance status 0-2.

You may not qualify if:

• benign disease
• a diagnosis of inflammatory bowel disease
• patients physically unable to perform a CPET on a cycle ergometer
• patients having no surgery performed or interim emergency surgery
• patients lacking complete in-hospital morbidity and survival data.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator
• Maastricht University: collaborator

Study Sites (1)

University Hospitals Southampton

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases; Neoplasms; Sarcopenia

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Digestive System Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Malcolm West, PhD

  University Hospitals Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malcolm West, PhD

CONTACT

m.west@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 21, 2018
• Study Start: January 1, 2017
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)