Cancer, Cancer, Metastatic, Cancer of Esophagus, Cancer of Liver, Cancer of Pancreas, Cancer of Stomach
Conditions
Keywords
Cancer, Muscle mass, Muscle strength, Complications, Patient reported outcomes, PRO, Physical function
Brief summary
PURPOSE: To determine the prognostic properties of a comprehensive evaluation of body composition and physical function in patients with GI-HEP cancer from point of diagnosis and throughout the treatment trajectory. GI-HEP: Patients with tumors of the upper gastrointestinal or hepatobiliary tract, specifically tumors of the esophagus, gastro-esophageal junction, stomach, primary tumors of the liver or biliary tract, as well as colorectal liver metastasis or tumors of the pancreas.
Detailed description
RATIONAL: Patients diagnosed with GI-HEP cancer are faced with poor prognosis. The treatment is demanding and associated with severe deconditioning potentially leading to worse prognostic outcomes. To what extend patients body composition at the point of diagnoses, as well as changes in body composition throughout the cancer continuum is associated with cancer outcomes is currently not well-described, specifically if this should be part of standard clinical evaluation in order to optimize therapy-efficacy. Recent findings suggest that pathophysiological alterations in skeletal muscle mass and function can have significant implications for the risk of disease progression and long-term prognosis.
Interventions
None listed
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with histologically verified GI-HEP cancer
Exclusion criteria
* Age: \<18 * Pregnancy * Physical or mental disabilities precluding physical testing * Inability to read and understand Danish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Post-operative complications | From baseline to 30 days post surgery | Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher). |
| Cohort 2: Medical treatment complications | From baseline to 1 year follow-up | Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization duration | From baseline to 1 year follow-up | Total number days in hospital |
| Disease free survival | From baseline to 1 year follow-up | Risk of disease progression |
| Overall survival | From baseline to 1 year follow-up | Risk of mortality from any-cause |
| Change in whole body lean mass | From baseline to 6 months follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in appendicular lean mass | From baseline to 6 months follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in whole body fat percentage | From baseline to 6 months follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in visceral fat mass | From baseline to 6 months follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in bone mineral density | From baseline to 6 months follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in bone mineral content | From baseline to 6 months follow-up | Dual-energy X-ray Absorptiometry (DXA) scan |
| Change in Skeletal Muscle Index | From baseline to 6 months follow-up | L3 muscle area determined by Computed tomography scan (performed for clinical purpose) adjusted for hight |
| Change in lower body physical function | From baseline to 6 months follow-up | 30 seconds Sit-To-Stand test |
| Change in maximum leg power | From baseline to 6 months follow-up | Leg extensor power test (Nottingham Power rig) |
| Change in Walking capacity | From baseline to 6 months follow-up | Maximum 10 meter walking speed |
| Change in plasma total cholesterol concentration | From baseline to 6 months follow-up | Blood sample |
| Change in plasma HDL cholesterol | From baseline to 6 months follow-up | Blood sample |
| Change in plasma LDL cholesterol | From baseline to 6 months follow-up | Blood sample |
| Change in plasma triglycerides | From baseline to 6 months follow-up | Blood sample |
| Change in plasma HbA1C | From baseline to 6 months follow-up | Blood sample |
| Change in plasma glucose | From baseline to 6 months follow-up | Blood sample |
| Change in plasma insulin | From baseline to 6 months follow-up | Blood sample |
| Change in health-related quality of life | From baseline to 6 months follow-up | Functional Assessment of Cancer Therapy (FACT) questionnaire |
| Change in psychological distress | From baseline to 6 months follow-up | Hospital Anxiety and Depression Scale (HADS) questionnaire |
| Change in sleep quality | From baseline to 6 months follow-up | Pittsburgh Sleep Quality Index (PSQI) questionnaire |
| Change in physical activity level | From baseline to 6 months follow-up | International Physical Activity Questionnaire (IPAQ) short form |
| Change in hand grip strength | From baseline to 6 months follow-up | Maximum strength test by handgrip dynanometer |
| Change in stair-climbing capacity | From baseline to 6 months follow-up | Timed Stair-climbing test |
Countries
Denmark
Outcome results
None listed