CancerNCT03347162
Muscle Dysfunction in Gastrointestinal or Hepatobiliary Cancer
An observational study of Cancer and Cancer of Pancreas, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer of Pancreas, Cancer of Liver
- How many people
- 1,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with histologically verified GI-HEP cancer
Who cannot join
- Age: <18
- Pregnancy
- Physical or mental disabilities precluding physical testing
- Inability to read and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Post-operative complications
Incidens rate of post-operative complications (Clavien-Dindo grade 2 or higher).
Measured: From baseline to 30 days post surgery
Cohort 2: Medical treatment complications
Incidens rate of medical complications (dose-reduction, temporary or permanent discontinuation)
Measured: From baseline to 1 year follow-up
Secondary outcomes (26)
Hospitalization duration
Total number days in hospital
Measured: From baseline to 1 year follow-up
Disease free survival
Risk of disease progression
Measured: From baseline to 1 year follow-up
Overall survival
Risk of mortality from any-cause
Measured: From baseline to 1 year follow-up
Change in whole body lean mass
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: From baseline to 6 months follow-up
Change in appendicular lean mass
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: From baseline to 6 months follow-up
Change in whole body fat percentage
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: From baseline to 6 months follow-up
Change in visceral fat mass
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: From baseline to 6 months follow-up
Change in bone mineral density
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: From baseline to 6 months follow-up
Change in bone mineral content
Dual-energy X-ray Absorptiometry (DXA) scan
Measured: 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
Measured: From baseline to 6 months follow-up
Change in Walking capacity
Maximum 10 meter walking speed
Measured: From baseline to 6 months follow-up
Change in stair-climbing capacity
Timed Stair-climbing test
Measured: From baseline to 6 months follow-up
Change in lower body physical function
30 seconds Sit-To-Stand test
Measured: From baseline to 6 months follow-up
Change in maximum leg power
Leg extensor power test (Nottingham Power rig)
Measured: From baseline to 6 months follow-up
Change in hand grip strength
Maximum strength test by handgrip dynanometer
Measured: From baseline to 6 months follow-up
Change in plasma total cholesterol concentration
Blood sample
Measured: From baseline to 6 months follow-up
Change in plasma HDL cholesterol
Blood sample
Measured: From baseline to 6 months follow-up
Change in plasma LDL cholesterol
Blood sample
Measured: From baseline to 6 months follow-up
Change in plasma triglycerides
Blood sample
Measured: From baseline to 6 months follow-up
Change in plasma HbA1C
Blood sample
Measured: From baseline to 6 months follow-up
Change in plasma glucose
Blood sample
Measured: From baseline to 6 months follow-up
Change in plasma insulin
Blood sample
Measured: From baseline to 6 months follow-up
Change in health-related quality of life
Functional Assessment of Cancer Therapy (FACT) questionnaire
Measured: From baseline to 6 months follow-up
Change in psychological distress
Hospital Anxiety and Depression Scale (HADS) questionnaire
Measured: From baseline to 6 months follow-up
Change in sleep quality
Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: From baseline to 6 months follow-up
Change in physical activity level
International Physical Activity Questionnaire (IPAQ) short form
Measured: From baseline to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Frank Christensen, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jesper F Christensen, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347162
- Sponsor's protocol ID
- MuscleLab1.0
- Status last verified
- Jun 2023
- First submitted
- 12 Oct 2017
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Muscle Dysfunction in Patients With Gastrointestinal or Hepatobiliary Cancer - An Observational Study of Two Patient Cohorts
- ClinicalTrials.gov ID
- NCT03347162
- Acronym / sponsor ID
- MuscleLab1.0
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients diagnosed with histologically verified GI-HEP cancer
Key exclusion criteria (4 listed)
- Age: <18
- Pregnancy
- Physical or mental disabilities precluding physical testing
- Inability to read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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)
26 secondary outcomes
Hospitalization duration
Time frame: From baseline to 1 year follow-up
Disease free survival
Time frame: From baseline to 1 year follow-up
Overall survival
Time frame: From baseline to 1 year follow-up
Change in whole body lean mass
Time frame: From baseline to 6 months follow-up
Change in appendicular lean mass
Time frame: From baseline to 6 months follow-up
Change in whole body fat percentage
Time frame: From baseline to 6 months follow-up
Change in visceral fat mass
Time frame: From baseline to 6 months follow-up
Change in bone mineral density
Time frame: From baseline to 6 months follow-up
Change in bone mineral content
Time frame: From baseline to 6 months follow-up
Change in Skeletal Muscle Index
Time frame: From baseline to 6 months follow-up
Change in Walking capacity
Time frame: From baseline to 6 months follow-up
Change in stair-climbing capacity
Time frame: From baseline to 6 months follow-up
Change in lower body physical function
Time frame: From baseline to 6 months follow-up
Change in maximum leg power
Time frame: From baseline to 6 months follow-up
Change in hand grip strength
Time frame: From baseline to 6 months follow-up
Change in plasma total cholesterol concentration
Time frame: From baseline to 6 months follow-up
Change in plasma HDL cholesterol
Time frame: From baseline to 6 months follow-up
Change in plasma LDL cholesterol
Time frame: From baseline to 6 months follow-up
Change in plasma triglycerides
Time frame: From baseline to 6 months follow-up
Change in plasma HbA1C
Time frame: From baseline to 6 months follow-up
Change in plasma glucose
Time frame: From baseline to 6 months follow-up
Change in plasma insulin
Time frame: From baseline to 6 months follow-up
Change in health-related quality of life
Time frame: From baseline to 6 months follow-up
Change in psychological distress
Time frame: From baseline to 6 months follow-up
Change in sleep quality
Time frame: From baseline to 6 months follow-up
Change in physical activity level
Time frame: From baseline to 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper F Christensen, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer of Pancreas, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Post-operative complications (time frame: From baseline to 30 days post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.