Rigshospitalet
Copenhagen, Denmark
NCT Number: NCT06137508
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?
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Copenhagen, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline, 9 and 18 weeks
CT assessed changes in skeletal muscle index at L3 (cm2/m2)
Time frame: Until 3 years after inclusion
Proportion of patients who have not died from gastroesophageal cancer.
Time frame: 1, 2, and 3 years after inclusion
Proportion of patients who have not died.
Time frame: 1, 2, and 3 years after inclusion
Time to progression.
Time frame: Baseline, 9 and 18 weeks
Unscheduled hospitalization
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance assessed by the delivery of chemotherapy (number of series received)
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)
Time frame: Baseline, 9 and 18 weeks
Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)
Time frame: Baseline, 9 and 18 weeks
Changes in hand grip strength, assessed using a dynamometer
Time frame: Baseline, 9 and 18 weeks
Changes in sit-to-stand power
Time frame: Baseline, 9 and 18 weeks
Explorative analysis of molecular factors expressed in plasma, skeletal muscle- and adipose tissue associated with changes in skeletal muscle mass.
Rigshospitalet, Denmark
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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