Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

Active, not recruiting

• Conditions: Cancer of Esophagus; Cancer; Cancer of Stomach; Cancer, Metastatic; Cancer of Pancreas; Cancer of Liver

• Registration Number: NCT03347162
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-20
• Study Start: 2017-12-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall survival	From baseline to 1 year follow-up	Risk of mortality from any-cause
Change in whole body fat percentage	From baseline to 6 months follow-up	Dual-energy X-ray Absorptiometry (DXA) scan
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
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 hand grip strength	From baseline to 6 months follow-up	Maximum strength test by handgrip dynanometer
Change in plasma HbA1C	From baseline to 6 months follow-up	Blood sample
Change in psychological distress	From baseline to 6 months follow-up	Hospital Anxiety and Depression Scale (HADS) questionnaire
Change in physical activity level	From baseline to 6 months follow-up	International Physical Activity Questionnaire (IPAQ) short form
Change in whole body lean mass	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 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 glucose	From baseline to 6 months follow-up	Blood sample
Change in appendicular lean mass	From baseline to 6 months follow-up	Dual-energy X-ray Absorptiometry (DXA) scan
Change in stair-climbing capacity	From baseline to 6 months follow-up	Timed Stair-climbing test
Change in plasma triglycerides	From baseline to 6 months follow-up	Blood sample
Change in plasma insulin	From baseline to 6 months follow-up	Blood sample
Change in sleep quality	From baseline to 6 months follow-up	Pittsburgh Sleep Quality Index (PSQI) questionnaire
Change in plasma LDL cholesterol	From baseline to 6 months follow-up	Blood sample
Change in Walking capacity	From baseline to 6 months follow-up	Maximum 10 meter walking speed
Change in health-related quality of life	From baseline to 6 months follow-up	Functional Assessment of Cancer Therapy (FACT) questionnaire

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark