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OpenTrials
Active, Not Recruiting

NCT Number: NCT03347162

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Cancer of Esophagus Cancer of Liver Cancer of Pancreas Cancer of Stomach Cancer, Metastatic Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Liver Diseases Liver Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. Hospitalization duration

    Time frame: From baseline to 1 year follow-up

    Total number days in hospital

  2. Disease free survival

    Time frame: From baseline to 1 year follow-up

    Risk of disease progression

  3. Overall survival

    Time frame: From baseline to 1 year follow-up

    Risk of mortality from any-cause

  4. Change in whole body lean mass

    Time frame: From baseline to 6 months follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  5. Change in appendicular lean mass

    Time frame: From baseline to 6 months follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  6. Change in whole body fat percentage

    Time frame: From baseline to 6 months follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  7. Change in visceral fat mass

    Time frame: From baseline to 6 months follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  8. Change in bone mineral density

    Time frame: From baseline to 6 months follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  9. Change in bone mineral content

    Time frame: From baseline to 6 months follow-up

    Dual-energy X-ray Absorptiometry (DXA) scan

  10. 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

  11. Change in Walking capacity

    Time frame: From baseline to 6 months follow-up

    Maximum 10 meter walking speed

  12. Change in stair-climbing capacity

    Time frame: From baseline to 6 months follow-up

    Timed Stair-climbing test

  13. Change in lower body physical function

    Time frame: From baseline to 6 months follow-up

    30 seconds Sit-To-Stand test

  14. Change in maximum leg power

    Time frame: From baseline to 6 months follow-up

    Leg extensor power test (Nottingham Power rig)

  15. Change in hand grip strength

    Time frame: From baseline to 6 months follow-up

    Maximum strength test by handgrip dynanometer

  16. Change in plasma total cholesterol concentration

    Time frame: From baseline to 6 months follow-up

    Blood sample

  17. Change in plasma HDL cholesterol

    Time frame: From baseline to 6 months follow-up

    Blood sample

  18. Change in plasma LDL cholesterol

    Time frame: From baseline to 6 months follow-up

    Blood sample

  19. Change in plasma triglycerides

    Time frame: From baseline to 6 months follow-up

    Blood sample

  20. Change in plasma HbA1C

    Time frame: From baseline to 6 months follow-up

    Blood sample

  21. Change in plasma glucose

    Time frame: From baseline to 6 months follow-up

    Blood sample

  22. Change in plasma insulin

    Time frame: From baseline to 6 months follow-up

    Blood sample

  23. Change in health-related quality of life

    Time frame: From baseline to 6 months follow-up

    Functional Assessment of Cancer Therapy (FACT) questionnaire

  24. Change in psychological distress

    Time frame: From baseline to 6 months follow-up

    Hospital Anxiety and Depression Scale (HADS) questionnaire

  25. Change in sleep quality

    Time frame: From baseline to 6 months follow-up

    Pittsburgh Sleep Quality Index (PSQI) questionnaire

  26. Change in physical activity level

    Time frame: From baseline to 6 months follow-up

    International Physical Activity Questionnaire (IPAQ) short form

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2026
First posted
Nov 20, 2017
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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