Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

Rigshospitalet

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT03347162

MuscleLab1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Cohort 1 - Resectable patients

Description:

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

Description:

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.