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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03347162
Other study ID # MuscleLab1.0
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 31, 2026

Study information

Verified date June 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1000
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cohort 1: Post-operative complications Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher). From baseline to 30 days post surgery
Primary Cohort 2: Medical treatment complications Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation) From baseline to 1 year follow-up
Secondary Hospitalization duration Total number days in hospital From baseline to 1 year follow-up
Secondary Disease free survival Risk of disease progression From baseline to 1 year follow-up
Secondary Overall survival Risk of mortality from any-cause From baseline to 1 year follow-up
Secondary Change in whole body lean mass Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 6 months follow-up
Secondary Change in appendicular lean mass Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 6 months follow-up
Secondary Change in whole body fat percentage Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 6 months follow-up
Secondary Change in visceral fat mass Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 6 months follow-up
Secondary Change in bone mineral density Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 6 months follow-up
Secondary Change in bone mineral content Dual-energy X-ray Absorptiometry (DXA) scan From baseline to 6 months follow-up
Secondary Change in Skeletal Muscle Index L3 muscle area determined by Computed tomography scan (performed for clinical purpose) adjusted for hight From baseline to 6 months follow-up
Secondary Change in Walking capacity Maximum 10 meter walking speed From baseline to 6 months follow-up
Secondary Change in stair-climbing capacity Timed Stair-climbing test From baseline to 6 months follow-up
Secondary Change in lower body physical function 30 seconds Sit-To-Stand test From baseline to 6 months follow-up
Secondary Change in maximum leg power Leg extensor power test (Nottingham Power rig) From baseline to 6 months follow-up
Secondary Change in hand grip strength Maximum strength test by handgrip dynanometer From baseline to 6 months follow-up
Secondary Change in plasma total cholesterol concentration Blood sample From baseline to 6 months follow-up
Secondary Change in plasma HDL cholesterol Blood sample From baseline to 6 months follow-up
Secondary Change in plasma LDL cholesterol Blood sample From baseline to 6 months follow-up
Secondary Change in plasma triglycerides Blood sample From baseline to 6 months follow-up
Secondary Change in plasma HbA1C Blood sample From baseline to 6 months follow-up
Secondary Change in plasma glucose Blood sample From baseline to 6 months follow-up
Secondary Change in plasma insulin Blood sample From baseline to 6 months follow-up
Secondary Change in health-related quality of life Functional Assessment of Cancer Therapy (FACT) questionnaire From baseline to 6 months follow-up
Secondary Change in psychological distress Hospital Anxiety and Depression Scale (HADS) questionnaire From baseline to 6 months follow-up
Secondary Change in sleep quality Pittsburgh Sleep Quality Index (PSQI) questionnaire From baseline to 6 months follow-up
Secondary Change in physical activity level International Physical Activity Questionnaire (IPAQ) short form From baseline to 6 months follow-up
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