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

May 22, 2026 updated by: Institute of Oncology Ljubljana

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

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 evaluated the proportion of patients with gastrointestinal cancer who were 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 could be referred for further nutritional evaluation and assessment of sarcopenia severity using anthropometric measurements and DXA, according to standard clinical practice.

Study Overview

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 prospective observational cohort study evaluated the proportion of patients with gastrointestinal cancers treated at the Institute of Oncology Ljubljana who screened positive for sarcopenia risk using the SARC-F questionnaire before initiation of systemic treatment and during treatment. The study also assessed changes in the proportion of patients at risk over time.

Patients with a positive SARC-F screening result could 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 could be introduced as part of routine clinical care.

The study was conducted over a two-year period.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with gastrointestinal cancers treated at the Institute of Oncology Ljubljana, receiving systemic therapy either in the adjuvant setting or for metastatic disease. Patients will be screened for sarcopenia risk using the SARC-F questionnaire before treatment initiation and during systemic therapy.

Description

Inclusion Criteria:

  • Adult patients (≥18 years) with gastrointestinal cancer
  • Patients planned for or receiving systemic anticancer treatment (adjuvant treatment or treatment of metastatic disease)
  • Ability to complete the SARC-F screening questionnaire
  • Written informed consent provided

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients unable to complete the questionnaire (e.g., severe cognitive impairment or inability to cooperate)
  • Patients not eligible for systemic anticancer treatment
  • Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gastrointestinal Cancer Patients
Patients with gastrointestinal cancer receiving systemic treatment (adjuvant or metastatic setting) at the Institute of Oncology Ljubljana. Participants will be screened for sarcopenia risk using the SARC-F questionnaire at baseline and during treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of gastrointestinal cancer patients with positive SARC-F screening
Time Frame: Baseline (before start of systemic treatment) and during systemic treatment (after 3 months)
Percentage of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire. A SARC-F score ≥4 will be considered positive.
Baseline (before start of systemic treatment) and during systemic treatment (after 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

December 19, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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