Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery

Usefulness of Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation and Complication Prediction in Oncological Patients Undergoing Colorectal Surgery

Sarcopenia is a complex syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength. In patients with cancer, sarcopenia is associated with poorer prognosis, increased treatment-related toxicity, higher postoperative complication rates, reduced response to therapy, and decreased quality of life. Importantly, sarcopenia may be present even in patients with preserved nutritional status or overweight.

Patients with gastrointestinal cancers are at particularly high risk of developing sarcopenia, both as a consequence of the malignant disease itself and as a result of systemic anticancer treatment. Early identification of patients at risk is therefore essential in order to enable timely nutritional and supportive interventions.

The aim of this study is to evaluate the proportion of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire before the start of systemic treatment and during treatment. Patients with a positive screening result will be referred for further clinical nutritional assessment and managed according to a multidisciplinary approach.

Study Overview

• Status: Recruiting
• Conditions: Digestive System Neoplasms; Gastrointestinal Cancer
• Intervention / Treatment: Drug: Cetuximab (CRC)

Detailed Description

Sarcopenia is recognized as an important negative prognostic factor in oncology, independent of malnutrition. It contributes to increased morbidity and mortality, higher incidence of treatment-related toxicity, reduced tolerance to systemic therapy, and impaired functional status. In patients with gastrointestinal malignancies, sarcopenia is common due to tumor-related metabolic changes, reduced intake, inflammation, and the adverse effects of anticancer therapies.

The SARC-F questionnaire is a simple, validated screening tool recommended by the European Working Group on Sarcopenia in Older People (EWGSOP2) for the identification of individuals at risk of sarcopenia. It consists of short, function-oriented questions assessing strength, assistance in walking, rising from a chair, climbing stairs, and falls. A SARC-F score of ≥4 indicates increased risk of sarcopenia.

This prospective interventional study will include adult patients with gastrointestinal cancer who are candidates for systemic anticancer treatment. Participants will complete the SARC-F questionnaire at baseline, prior to initiation of systemic therapy, and again during treatment. The primary objective is to determine the proportion of patients with positive SARC-F screening results at these time points and to evaluate changes in sarcopenia risk during the course of treatment.

Patients who screen positive for sarcopenia risk will be referred to the clinical nutrition outpatient clinic for further assessment, including anthropometric measurements and, where clinically indicated, dual-energy X-ray absorptiometry (DXA). Based on the results, individualized multimodal interventions for the prevention and treatment of sarcopenia will be initiated in collaboration with a multidisciplinary team.

The study does not impose additional diagnostic or therapeutic burden beyond standard clinical care. The results are expected to contribute to improved early identification and management of sarcopenia in patients with gastrointestinal cancer.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Klavdija Korošec; Phone Number: +386 31630065; Email: kkorosec@onko-i.si
• Study Contact Backup: Name: Neža Gros; Email: ngros@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Klavdija Korošec; Phone Number: +386 31630065; Email: kkorosec@onko-i.si
    • Contact: Neža Gros; Email: ngros@onko-i.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adult patients (≥18 years of age).

Histologically confirmed head and neck cancer.

Indication for induction chemotherapy followed by chemoradiotherapy with cetuximab.

Adequate organ function as required by the study protocol.

Ability to provide informed consent.

Exclusion Criteria:

• Prior systemic therapy or radiotherapy for head and neck cancer.

Presence of uncontrolled comorbidities that would preclude study treatment.

Known hypersensitivity to cetuximab or components of the treatment regimen.

Pregnancy or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; Patients receive induction chemotherapy followed by chemoradiotherapy with cetuximab.	Drug: Cetuximab (CRC); Cetuximab is administered in combination with induction chemotherapy followed by concurrent chemoradiotherapy, according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall survival is defined as the time from study enrollment to death from any cause	Up to 5 years

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: SARC-F
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab
• Other Study ID Numbers: OI-2023-BIA; ERIDNPVO-0070/2023 (Other Identifier: Ethics Committee of the Institute of Oncology Ljubljana)

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