Gastro-Esophageal CancerNCT06137508
Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer
An observational study of Gastro-Esophageal Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Patients with incurable gastroesophageal cancer are at high risk of cancer cachexia with an estimated prevalence of 60-80%. Cancer cachexia is defined as ongoing loss of skeletal muscle mass with or without loss of fat mass and is associated with impaired quality of life, loss of physical function, treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-Esophageal Cancer
- How many people
- 125 participants
- Where
- 1 siteDenmark
- Study dates
- 10 May 2024to Dec 2028
- How long will I take part?
- 3 Years
- 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: Patients diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.
Who may be able to join
- Patients eligible for participation are any patient diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Patients with incurable gastroesophageal cancer are at high risk of cancer cachexia with an estimated prevalence of 60-80%. Cancer cachexia is defined as ongoing loss of skeletal muscle mass with or without loss of fat mass and is associated with impaired quality of life, loss of physical function, treatment intolerability, and increased mortality.
Cancer cachexia is a multifactorial syndrome, and in patients with gastroesophageal cancer, the wasting is compounded by a high prevalence of dysphagia. To date, no drug therapy has been approved for the treatment for cancer cachexia. Sufficient nutritional support is imperative in cachexia treatment, but to effectively treat cancer cachexia there is a need to fully understand the biological mechanisms underpinning the wasting syndrome.
Read more
The primary objective of the present cohort study is to determine the incidence and extend of skeletal muscle wasting in patients with incurable gastroesophageal cancer. The investigators will also investigate the prevalence of low skeletal muscle at time of diagnosis. The secondary objective is to investigate, if loss of skeletal muscle is associated with treatment intolerance and increased mortality.
Furthermore, the investigators aim to explore factors differentially expressed in the circulation, in skeletal muscle, and in adipose tissue of patients experiencing wasting compared with patients not experiencing wasting.
The study is a prospective cohort study including patients with incurable gastroesophageal cancer referred to first line chemotherapy. Blood and plasma samples as well as clinical and simple functional assessments will be obtained from all patients. The participants will also be offered to take part in a sub-study in which, we will collect skeletal muscle and subcutaneous adipose tissue.
The main questions the investigators aim to answer are:
- What is the prevalence and extent of skeletal muscle mass wasting in patients with incurable gastroesophageal cancer?
- Are the loss of skeletal muscle mass and low skeletal muscle mass associated with treatment intolerability and overall survival in patients with incurable gastroesophageal cancer?
- Can there be identified potential biological processes and factors in skeletal muscle, adipose tissue, and plasma that contribute to the loss of skeletal muscle mass in patients with incurable gastroesophageal cancer?
- Conditions
- Gastro-Esophageal Cancer
- Keywords
- Cancer, Cancer Cachexia, Sarcopenia, Neoplasms, Metabolism
- Medical subject headings
- Neoplasms, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle area
CT assessed changes in skeletal muscle index at L3 (cm2/m2)
Measured: Baseline, 9 and 18 weeks
Secondary outcomes (10)
Cancer-specific survival
Proportion of patients who have not died from gastroesophageal cancer.
Measured: Until 3 years after inclusion
Over-all survival
Proportion of patients who have not died.
Measured: 1, 2, and 3 years after inclusion
Progression-free survival
Time to progression.
Measured: 1, 2, and 3 years after inclusion
Treatment tolerance: Hospitalization
Unscheduled hospitalization
Measured: Baseline, 9 and 18 weeks
Treatment tolerance: Relative dose intensity
Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)
Measured: Baseline, 9 and 18 weeks
Treatment tolerance: Number of series received
Treatment tolerance assessed by the delivery of chemotherapy (number of series received)
Measured: Baseline, 9 and 18 weeks
Treatment tolerance: Tolerated dose
Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)
Measured: Baseline, 9 and 18 weeks
Treatment tolerance: Permanent discontinuation of the treatment
Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)
Measured: Baseline, 9 and 18 weeks
Muscle strength: Hand grip strength
Changes in hand grip strength, assessed using a dynamometer
Measured: Baseline, 9 and 18 weeks
Functional performance: Sit-to-stand
Changes in sit-to-stand power
Measured: Baseline, 9 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 May 2024
- Primary completion30 Mar 2026
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Esophageal 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
- 125 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rikke Krabek, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Casper Simonsen, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137508
- Sponsor's protocol ID
- H-23050300
- Status last verified
- May 2026
- First submitted
- 13 Nov 2023
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer
- ClinicalTrials.gov ID
- NCT06137508
- Acronym / sponsor ID
- H-23050300
- Conditions
- Gastro-Esophageal Cancer
- Keywords
- Cancer, Cancer Cachexia, Sarcopenia, Neoplasms, Metabolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Nov 2023 (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.
Patients with incurable gastroesophageal cancer are at high risk of cancer cachexia with an estimated prevalence of 60-80%. Cancer cachexia is defined as ongoing loss of skeletal muscle mass with or without loss of fat mass and is associated with impaired quality of life, loss of physical function, treatment intolerability, and increased mortality.
Cancer cachexia is a multifactorial syndrome, and in patients with gastroesophageal cancer, the wasting is compounded by a high prevalence of dysphagia. To date, no drug therapy has been approved for the treatment for cancer cachexia. Sufficient nutritional support is imperative in cachexia treatment, but to effectively treat cancer cachexia there is a need to fully understand the biological mechanisms underpinning the wasting syndrome.
The primary objective of the present cohort study is to determine the incidence and extend of skeletal muscle wasting in patients with incurable gastroesophageal cancer. The investigators will also investigate the prevalence of low skeletal muscle at time of diagnosis. The secondary objective is to investigate, if loss of skeletal muscle is associated with treatment intolerance and increased mortality.
Furthermore, the investigators aim to explore factors differentially expressed in the circulation, in skeletal muscle, and in adipose tissue of patients experiencing wasting compared with patients not experiencing wasting.
The study is a prospective cohort study including patients with incurable gastroesophageal cancer referred to first line chemotherapy. Blood and plasma samples as well as clinical and simple functional assessments will be obtained from all patients. The participants will also be offered to take part in a sub-study in which, we will collect skeletal muscle and subcutaneous adipose tissue.
The main questions the investigators aim to answer are:
- What is the prevalence and extent of skeletal muscle mass wasting in patients with incurable gastroesophageal cancer?
- Are the loss of skeletal muscle mass and low skeletal muscle mass associated with treatment intolerability and overall survival in patients with incurable gastroesophageal cancer?
- Can there be identified potential biological processes and factors in skeletal muscle, adipose tissue, and plasma that contribute to the loss of skeletal muscle mass in patients with incurable gastroesophageal cancer?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.
Key inclusion criteria (1 listed)
- Patients eligible for participation are any patient diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.
Key exclusion criteria (1 listed)
- Age < 18 years
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
Skeletal muscle area
Time frame: Baseline, 9 and 18 weeks
CT assessed changes in skeletal muscle index at L3 (cm2/m2)
10 secondary outcomes
Cancer-specific survival
Time frame: Until 3 years after inclusion
Over-all survival
Time frame: 1, 2, and 3 years after inclusion
Progression-free survival
Time frame: 1, 2, and 3 years after inclusion
Treatment tolerance: Hospitalization
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance: Relative dose intensity
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance: Number of series received
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance: Tolerated dose
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance: Permanent discontinuation of the treatment
Time frame: Baseline, 9 and 18 weeks
Muscle strength: Hand grip strength
Time frame: Baseline, 9 and 18 weeks
Functional performance: Sit-to-stand
Time frame: Baseline, 9 and 18 weeks
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 14 May 2026.
- Individual participant dataSharing planned: No
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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.
Casper Simonsen, 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 Gastro-Esophageal Cancer, 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 1 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 14 May 2026. 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?
Skeletal muscle area (time frame: Baseline, 9 and 18 weeks). 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 14 May 2026.