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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:
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| Measure | Description | Time Frame |
|---|---|---|
| Skeletal muscle area | CT assessed changes in skeletal muscle index at L3 (cm2/m2) | Baseline, 9 and 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-specific survival | Proportion of patients who have not died from gastroesophageal cancer. | Until 3 years after inclusion |
| Over-all survival | Proportion of patients who have not died. |
| Measure | Description | Time Frame |
|---|---|---|
| Molecular factors associated with changes in skeletal muscle mass | Explorative analysis of molecular factors expressed in plasma, skeletal muscle- and adipose tissue associated with changes in skeletal muscle mass. | Baseline, 9 and 18 weeks |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Casper Simonsen, PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 1, 2, and 3 years after inclusion |
| Progression-free survival | Time to progression. | 1, 2, and 3 years after inclusion |
| Treatment tolerance: Hospitalization | Unscheduled hospitalization | Baseline, 9 and 18 weeks |
| Treatment tolerance: Relative dose intensity | Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity) | Baseline, 9 and 18 weeks |
| Treatment tolerance: Number of series received | Treatment tolerance assessed by the delivery of chemotherapy (number of series received) | Baseline, 9 and 18 weeks |
| Treatment tolerance: Tolerated dose | Treatment tolerance assessed by the delivery of chemotherapy (dose reduction) | 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) | Baseline, 9 and 18 weeks |
| Muscle strength: Hand grip strength | Changes in hand grip strength, assessed using a dynamometer | Baseline, 9 and 18 weeks |
| Functional performance: Sit-to-stand | Changes in sit-to-stand power | Baseline, 9 and 18 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |