Clinical trial · Observational
Sarcopenia and Physiology Assessments in Cancer Patients
Assessment of Measures of Sarcopenia and Whole Body Physiology in Cancer Patients and Their Relationship to Surgical Outcome and Survival
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatobiliary Cancer | Malignant Hepatobiliary Neoplasm | ALIAS | 0.90 |
| Lower Gastrointestinal Disorders | — | UNRESOLVED | — |
| Upper Gastrointestinal Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary exercise test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Lower gastrointestinal cancer
- description
- All lower gastrointestinal neoplasms including rectal
- interventionNames
- Diagnostic Test: Cardiopulmonary exercise test
- label
- Upper gastrointestinal cancer
- description
- All upper gastrointestinal neoplasms
- interventionNames
- Diagnostic Test: Cardiopulmonary exercise test
- label
- Hepatobiliary cancers
- description
- All liver, pancreas, biliary cancer
- interventionNames
- Diagnostic Test: Cardiopulmonary exercise test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients * aged over 18 years old * undergoing surgery and/or cancer therapies * WHO performance status 0-2. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available