Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cancer; Cancer of Liver; Cancer of Pancreas; Cancer of Stomach; Cancer of Esophagus; 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

GI-HEP cancer specified as tumors of the esophagus, gastroesophageal junction, stomach, primary tumors of the liver and biliary tract. As well as colorectal liver metastasis and tumors of the pancreas.

The study will include patients who are candidates for tumor resection and patients who are not candidates for surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Post-operative complications	Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher).	From baseline to 30 days post surgery
Cohort 2: Medical treatment complications	Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation)	From baseline to 1 year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization duration	Total number days in hospital	From baseline to 1 year follow-up
Disease free survival	Risk of disease progression	From baseline to 1 year follow-up
Overall survival	Risk of mortality from any-cause	From baseline to 1 year follow-up
Change in whole body lean mass	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Change in appendicular lean mass	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Change in whole body fat percentage	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Change in visceral fat mass	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Change in bone mineral density	Dual-energy X-ray Absorptiometry (DXA) scan	From baseline to 6 months follow-up
Change in bone mineral content	Dual-energy X-ray Absorptiometry (DXA) scan	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	From baseline to 6 months follow-up
Change in Walking capacity	Maximum 10 meter walking speed	From baseline to 6 months follow-up
Change in stair-climbing capacity	Timed Stair-climbing test	From baseline to 6 months follow-up
Change in lower body physical function	30 seconds Sit-To-Stand test	From baseline to 6 months follow-up
Change in maximum leg power	Leg extensor power test (Nottingham Power rig)	From baseline to 6 months follow-up
Change in hand grip strength	Maximum strength test by handgrip dynanometer	From baseline to 6 months follow-up
Change in plasma total cholesterol concentration	Blood sample	From baseline to 6 months follow-up
Change in plasma HDL cholesterol	Blood sample	From baseline to 6 months follow-up
Change in plasma LDL cholesterol	Blood sample	From baseline to 6 months follow-up
Change in plasma triglycerides	Blood sample	From baseline to 6 months follow-up
Change in plasma HbA1C	Blood sample	From baseline to 6 months follow-up
Change in plasma glucose	Blood sample	From baseline to 6 months follow-up
Change in plasma insulin	Blood sample	From baseline to 6 months follow-up
Change in health-related quality of life	Functional Assessment of Cancer Therapy (FACT) questionnaire	From baseline to 6 months follow-up
Change in psychological distress	Hospital Anxiety and Depression Scale (HADS) questionnaire	From baseline to 6 months follow-up
Change in sleep quality	Pittsburgh Sleep Quality Index (PSQI) questionnaire	From baseline to 6 months follow-up
Change in physical activity level	International Physical Activity Questionnaire (IPAQ) short form	From baseline to 6 months follow-up

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Jesper F Christensen, PhD, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Patient reported outcomes; Cancer; Complications; Muscle strength; PRO; Physical function; Muscle mass
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Liver Diseases; Head and Neck Neoplasms; Esophageal Diseases; Pancreatic Diseases; Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: MuscleLab1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No