Clinical trial NCT03347162: Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer
Official title: Prognostic Role of Muscle Dysfunction in Patients With Gastrointestinal or Hepatobiliary Cancer - An Observational Study of Two Patient Cohorts
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer
Cancer of Pancreas
Cancer of Liver
Cancer of Esophagus
Cancer of Stomach
Cancer, Metastatic
Keywords: Cancer
Muscle mass
Muscle strength
Complications
Patient reported outcomes
PRO
Physical function
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cohort 1: Post-operative complications
timeFrame: From baseline to 30 days post surgery
measure: Cohort 2: Medical treatment complications
timeFrame: From baseline to 1 year follow-up
Secondary outcomes:
measure: Hospitalization duration
timeFrame: From baseline to 1 year follow-up
measure: Disease free survival
timeFrame: From baseline to 1 year follow-up
measure: Overall survival
timeFrame: From baseline to 1 year follow-up
measure: Change in whole body lean mass
timeFrame: From baseline to 6 months follow-up
measure: Change in appendicular lean mass
timeFrame: From baseline to 6 months follow-up
measure: Change in whole body fat percentage
timeFrame: From baseline to 6 months follow-up
measure: Change in visceral fat mass
timeFrame: From baseline to 6 months follow-up
measure: Change in bone mineral density
timeFrame: From baseline to 6 months follow-up
measure: Change in bone mineral content
timeFrame: From baseline to 6 months follow-up
measure: Change in Skeletal Muscle Index
timeFrame: From baseline to 6 months follow-up
measure: Change in Walking capacity
timeFrame: From baseline to 6 months follow-up
measure: Change in stair-climbing capacity
timeFrame: From baseline to 6 months follow-up
measure: Change in lower body physical function
timeFrame: From baseline to 6 months follow-up
measure: Change in maximum leg power
timeFrame: From baseline to 6 months follow-up
measure: Change in hand grip strength
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma total cholesterol concentration
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma HDL cholesterol
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma LDL cholesterol
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma triglycerides
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma HbA1C
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma glucose
timeFrame: From baseline to 6 months follow-up
measure: Change in plasma insulin
timeFrame: From baseline to 6 months follow-up
measure: Change in health-related quality of life
timeFrame: From baseline to 6 months follow-up
measure: Change in psychological distress
timeFrame: From baseline to 6 months follow-up
measure: Change in sleep quality
timeFrame: From baseline to 6 months follow-up
measure: Change in physical activity level
timeFrame: From baseline to 6 months follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jesper F Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: