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2017-12-01
2025-12-31
2026-12-31
1000
NCT03347162
Rigshospitalet, Denmark
Rigshospitalet, Denmark
OBSERVATIONAL
Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer
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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-10-12 | N/A | 2023-06-19 |
2017-11-16 | N/A | 2023-06-22 |
2017-11-20 | N/A | 2023-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/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. |
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
