RecruitingNCT06137508

Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer


Sponsor

Rigshospitalet, Denmark

Enrollment

125 participants

Start Date

May 10, 2024

Study Type

OBSERVATIONAL

Conditions

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 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?


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is looking at cancer-related cachexia — the severe weight loss and muscle wasting that often affects people with advanced stomach or esophageal cancer — to better understand how it develops and changes during treatment. Researchers hope to find ways to better identify and manage this condition. **You may be eligible if...** - You have been diagnosed with incurable (non-curable) cancer of the esophagus, stomach, or the junction between them (gastroesophageal junction), confirmed by biopsy - You are being referred for first-line chemotherapy - You are 18 years of age or older **You may NOT be eligible if...** - You are under 18 years of age - You do not have a confirmed histological diagnosis of esophageal, stomach, or GEJ cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Rigshospitalet

Copenhagen, Denmark

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NCT06137508


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