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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Rigshospitalet
Copenhagen, Denmark
Cohort 1: Post-operative complications
Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher).
Time frame: From baseline to 30 days post surgery
Cohort 2: Medical treatment complications
Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation)
Time frame: From baseline to 1 year follow-up
Hospitalization duration
Total number days in hospital
Time frame: From baseline to 1 year follow-up
Disease free survival
Risk of disease progression
Time frame: From baseline to 1 year follow-up
Overall survival
Risk of mortality from any-cause
Time frame: From baseline to 1 year follow-up
Change in whole body lean mass
Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: From baseline to 6 months follow-up
Change in appendicular lean mass
Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: From baseline to 6 months follow-up
Change in whole body fat percentage
Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: From baseline to 6 months follow-up
Change in visceral fat mass
Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: From baseline to 6 months follow-up
Change in bone mineral density
Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: From baseline to 6 months follow-up
Change in bone mineral content
Dual-energy X-ray Absorptiometry (DXA) scan
Time frame: From baseline to 6 months follow-up
Change in Skeletal Muscle Index
L3 muscle area determined by Computed tomography scan (performed for clinical purpose) adjusted for hight
Time frame: From baseline to 6 months follow-up
Change in Walking capacity
Maximum 10 meter walking speed
Time frame: From baseline to 6 months follow-up
Change in stair-climbing capacity
Timed Stair-climbing test
Time frame: From baseline to 6 months follow-up
Change in lower body physical function
30 seconds Sit-To-Stand test
Time frame: From baseline to 6 months follow-up
Change in maximum leg power
Leg extensor power test (Nottingham Power rig)
Time frame: From baseline to 6 months follow-up
Change in hand grip strength
Maximum strength test by handgrip dynanometer
Time frame: From baseline to 6 months follow-up
Change in plasma total cholesterol concentration
Blood sample
Time frame: From baseline to 6 months follow-up
Change in plasma HDL cholesterol
Blood sample
Time frame: From baseline to 6 months follow-up
Change in plasma LDL cholesterol
Blood sample
Time frame: From baseline to 6 months follow-up
Change in plasma triglycerides
Blood sample
Time frame: From baseline to 6 months follow-up
Change in plasma HbA1C
Blood sample
Time frame: From baseline to 6 months follow-up
Change in plasma glucose
Blood sample
Time frame: From baseline to 6 months follow-up
Change in plasma insulin
Blood sample
Time frame: From baseline to 6 months follow-up
Change in health-related quality of life
Functional Assessment of Cancer Therapy (FACT) questionnaire
Time frame: From baseline to 6 months follow-up
Change in psychological distress
Hospital Anxiety and Depression Scale (HADS) questionnaire
Time frame: From baseline to 6 months follow-up
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time frame: From baseline to 6 months follow-up
Change in physical activity level
International Physical Activity Questionnaire (IPAQ) short form
Time frame: From baseline to 6 months follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.