NCT07405307

Sarcopenia Risk Screening in Patients With Gastrointestinal Cancer Using SARC-F

Evaluation of the Proportion of Patients With Gastrointestinal Cancer Who Have Symptoms of Sarcopenia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass and strength and is associated with worse outcomes in cancer patients. It can negatively affect prognosis, increase postoperative complications, reduce tolerance to systemic therapy, and impair quality of life. Sarcopenia may be present even in patients with preserved nutritional status or overweight. This study aims to evaluate the proportion of patients with gastrointestinal cancer who are at risk of sarcopenia, as assessed by the SARC-F screening questionnaire, before initiation of systemic treatment and during treatment. Patients with a positive screening result may be referred for further nutritional evaluation and assessment of sarcopenia severity using anthropometric measurements and DXA, according to standard clinical practice.

Detailed description

Sarcopenia is a complex condition characterized by progressive and generalized loss of skeletal muscle mass and strength. In oncology patients, sarcopenia is associated with increased mortality, higher rates of postoperative complications, reduced response to systemic therapy, increased treatment-related toxicity, and decreased quality of life. Sarcopenia may occur independently of malnutrition and may also be present in patients with normal or increased body weight. Sarcopenia is not only related to the presence of malignant disease but may also develop or worsen as a consequence of oncological treatment. Several antineoplastic therapies have been shown to negatively affect muscle mass and function. Due to its significant negative clinical impact, early detection of sarcopenia risk is essential. The SARC-F questionnaire is a validated screening tool recommended by the European Working Group on Sarcopenia in Older People (EWGSOP2) for identifying individuals at risk of sarcopenia. This interventional study will evaluate the proportion of patients with gastrointestinal cancers treated at the Institute of Oncology Ljubljana who screen positive for sarcopenia risk using the SARC-F questionnaire before initiation of systemic treatment and during treatment. The study will also assess changes in the proportion of patients at risk over time. Patients with a positive SARC-F screening result may be referred to the clinical nutrition outpatient clinic for further evaluation, including anthropometric measurements and DXA assessment, in order to determine the severity of sarcopenia. Based on clinical evaluation and in agreement with the treating oncologist, multimodal and multidisciplinary preventive and therapeutic interventions may be introduced as part of routine clinical care. The study duration is planned for two years.

Conditions

• Gastrointestinal Cancer
• Sarcopenia

Interventions

Type	Name	Description
OTHER	Sarcopenia Screening and Nutritional Referral	Participants with a positive SARC-F screening result will be referred to the Clinical Nutrition Outpatient Clinic for further assessment of sarcopenia using anthropometric measurements and DXA, and for implementation of multidisciplinary interventions according to standard clinical practice.

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2026-02-12
• Last updated: 2026-02-17

Locations

1 site across 1 country: Slovenia