Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer

June 19, 2023 updated by: Jesper Frank Christensen, PhD, Rigshospitalet, Denmark

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cohort 1: Post-operative complications
Time Frame: From baseline to 30 days post surgery
Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher).
From baseline to 30 days post surgery
Cohort 2: Medical treatment complications
Time Frame: From baseline to 1 year follow-up
Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation)
From baseline to 1 year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalization duration
Time Frame: From baseline to 1 year follow-up
Total number days in hospital
From baseline to 1 year follow-up
Disease free survival
Time Frame: From baseline to 1 year follow-up
Risk of disease progression
From baseline to 1 year follow-up
Overall survival
Time Frame: From baseline to 1 year follow-up
Risk of mortality from any-cause
From baseline to 1 year follow-up
Change in whole body lean mass
Time Frame: From baseline to 6 months follow-up
Dual-energy X-ray Absorptiometry (DXA) scan
From baseline to 6 months follow-up
Change in appendicular lean mass
Time Frame: From baseline to 6 months follow-up
Dual-energy X-ray Absorptiometry (DXA) scan
From baseline to 6 months follow-up
Change in whole body fat percentage
Time Frame: From baseline to 6 months follow-up
Dual-energy X-ray Absorptiometry (DXA) scan
From baseline to 6 months follow-up
Change in visceral fat mass
Time Frame: From baseline to 6 months follow-up
Dual-energy X-ray Absorptiometry (DXA) scan
From baseline to 6 months follow-up
Change in bone mineral density
Time Frame: From baseline to 6 months follow-up
Dual-energy X-ray Absorptiometry (DXA) scan
From baseline to 6 months follow-up
Change in bone mineral content
Time Frame: From baseline to 6 months follow-up
Dual-energy X-ray Absorptiometry (DXA) scan
From baseline to 6 months follow-up
Change in Skeletal Muscle Index
Time Frame: From baseline to 6 months follow-up
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
Time Frame: From baseline to 6 months follow-up
Maximum 10 meter walking speed
From baseline to 6 months follow-up
Change in stair-climbing capacity
Time Frame: From baseline to 6 months follow-up
Timed Stair-climbing test
From baseline to 6 months follow-up
Change in lower body physical function
Time Frame: From baseline to 6 months follow-up
30 seconds Sit-To-Stand test
From baseline to 6 months follow-up
Change in maximum leg power
Time Frame: From baseline to 6 months follow-up
Leg extensor power test (Nottingham Power rig)
From baseline to 6 months follow-up
Change in hand grip strength
Time Frame: From baseline to 6 months follow-up
Maximum strength test by handgrip dynanometer
From baseline to 6 months follow-up
Change in plasma total cholesterol concentration
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in plasma HDL cholesterol
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in plasma LDL cholesterol
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in plasma triglycerides
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in plasma HbA1C
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in plasma glucose
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in plasma insulin
Time Frame: From baseline to 6 months follow-up
Blood sample
From baseline to 6 months follow-up
Change in health-related quality of life
Time Frame: From baseline to 6 months follow-up
Functional Assessment of Cancer Therapy (FACT) questionnaire
From baseline to 6 months follow-up
Change in psychological distress
Time Frame: From baseline to 6 months follow-up
Hospital Anxiety and Depression Scale (HADS) questionnaire
From baseline to 6 months follow-up
Change in sleep quality
Time Frame: From baseline to 6 months follow-up
Pittsburgh Sleep Quality Index (PSQI) questionnaire
From baseline to 6 months follow-up
Change in physical activity level
Time Frame: From baseline to 6 months follow-up
International Physical Activity Questionnaire (IPAQ) short form
From baseline to 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jesper F Christensen, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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