Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

Study Overview
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Brief Summary
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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: 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?

Official Title
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Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

Conditions
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Gastro-Esophageal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Age < 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle area | CT assessed changes in skeletal muscle index at L3 (cm2/m2) | Baseline, 9 and 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Cancer Cachexia, Sarcopenia, Neoplasms, Metabolism