Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03347162

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Cancer of Pancreas Cancer of Liver Cancer of Esophagus Cancer of Stomach Cancer, Metastatic

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prognostic Role of Muscle Dysfunction in Patients With Gastrointestinal or Hepatobiliary Cancer - An Observational Study of Two Patient Cohorts

Actual Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1 - Resectable patients These patients will undergo 3 assessments: a baseline-assessment prior to surgery, a post-surgery assessment (2 week post-surgery) and a follow-up assessment 6 months after surgery (after adjuvant oncology treatment).
Cohort 2 - Non-resectable patients These patients will undergoing 3 assessments: a baseline-assessment prior to palliative treatment, an acute measurement 4 weeks after initiation of palliative treatment, and a 6-month long-term assessment.

Outcome Measures

Primary Outcome Measures

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

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 Walking capacity [From baseline to 6 months follow-up]
Maximum 10 meter walking speed
Change in stair-climbing capacity [From baseline to 6 months follow-up]
Timed Stair-climbing test
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 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