Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

NCT06137508 | Active Not Recruiting

• 1 other identifier: H-23050300
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Gastro-Esophageal Cancer

Keywords

Cancer; Cancer Cachexia; Sarcopenia; Neoplasms; Metabolism

Outcome Measures

Primary Outcomes (1)

• Skeletal muscle area

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

  Baseline, 9 and 18 weeks

Secondary Outcomes (10)

• Cancer-specific survival

  Until 3 years after inclusion

• Over-all survival

  1, 2, and 3 years after inclusion

• Progression-free survival

  1, 2, and 3 years after inclusion

• Treatment tolerance: Hospitalization

  Baseline, 9 and 18 weeks

• Treatment tolerance: Relative dose intensity

  Baseline, 9 and 18 weeks

Other Outcomes (1)

• Molecular factors associated with changes in skeletal muscle mass

  Baseline, 9 and 18 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with histologically verified, incurable cancer of the esophagus, stomach, or gastroesophageal junction, referred to first line chemotherapy.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Casper Simonsen, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: May 10, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)