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OpenTrials
Active, Not Recruiting

NCT Number: NCT06137508

Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skeletal muscle area

    Time frame: Baseline, 9 and 18 weeks

    CT assessed changes in skeletal muscle index at L3 (cm2/m2)

Secondary outcomes

  1. Cancer-specific survival

    Time frame: Until 3 years after inclusion

    Proportion of patients who have not died from gastroesophageal cancer.

  2. Over-all survival

    Time frame: 1, 2, and 3 years after inclusion

    Proportion of patients who have not died.

  3. Progression-free survival

    Time frame: 1, 2, and 3 years after inclusion

    Time to progression.

  4. Treatment tolerance: Hospitalization

    Time frame: Baseline, 9 and 18 weeks

    Unscheduled hospitalization

  5. Treatment tolerance: Relative dose intensity

    Time frame: Baseline, 9 and 18 weeks

    Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)

  6. Treatment tolerance: Number of series received

    Time frame: Baseline, 9 and 18 weeks

    Treatment tolerance assessed by the delivery of chemotherapy (number of series received)

  7. Treatment tolerance: Tolerated dose

    Time frame: Baseline, 9 and 18 weeks

    Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)

  8. Treatment tolerance: Permanent discontinuation of the treatment

    Time frame: Baseline, 9 and 18 weeks

    Treatment tolerance assessed by the delivery of chemotherapy (permanent discontinuation of the treatment)

  9. Muscle strength: Hand grip strength

    Time frame: Baseline, 9 and 18 weeks

    Changes in hand grip strength, assessed using a dynamometer

  10. Functional performance: Sit-to-stand

    Time frame: Baseline, 9 and 18 weeks

    Changes in sit-to-stand power

Other outcomes

  1. Molecular factors associated with changes in skeletal muscle mass

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Nov 18, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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