Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

Gastro-Esophageal Cancer Clinical Trial

Official title:

Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06137508
• Other study ID #: H-23050300
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Rikke Krabek, MD
• Phone: +4535457641
• Email: rikke.krabek[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Gastro-Esophageal Cancer

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Molecular factors associated with changes in skeletal muscle mass	Explorative analysis of molecular factors expressed in plasma, skeletal muscle- and adipose tissue associated with changes in skeletal muscle mass.	Baseline, 9 and 18 weeks
Primary	Skeletal muscle area	CT assessed changes in skeletal muscle index at L3 (cm2/m2)	Baseline, 9 and 18 weeks
Secondary	Cancer-specific survival	Proportion of patients who have not died from gastroesophageal cancer.	Until 3 years after inclusion
Secondary	Over-all survival	Proportion of patients who have not died.	1, 2, and 3 years after inclusion
Secondary	Progression-free survival	Time to progression.	1, 2, and 3 years after inclusion
Secondary	Treatment tolerance: Hospitalization	Unscheduled hospitalization	Baseline, 9 and 18 weeks
Secondary	Treatment tolerance: Relative dose intensity	Treatment tolerance assessed by the delivery of chemotherapy (relative dose intensity)	Baseline, 9 and 18 weeks
Secondary	Treatment tolerance: Number of series received	Treatment tolerance assessed by the delivery of chemotherapy (number of series received)	Baseline, 9 and 18 weeks
Secondary	Treatment tolerance: Tolerated dose	Treatment tolerance assessed by the delivery of chemotherapy (dose reduction)	Baseline, 9 and 18 weeks
Secondary	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
Secondary	Muscle strength: Hand grip strength	Changes in hand grip strength, assessed using a dynamometer	Baseline, 9 and 18 weeks
Secondary	Functional performance: Sit-to-stand	Changes in sit-to-stand power	Baseline, 9 and 18 weeks