Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery

NCT07404527 | Recruiting

• 2 other identifiers: OI-2023-BIAERIDNPVO-0070/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Cancer; Digestive System Neoplasms

Keywords

SARC-F

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall survival is defined as the time from study enrollment to death from any cause

  Up to 5 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients receive induction chemotherapy followed by chemoradiotherapy with cetuximab.

Drug: Cetuximab (CRC)

Interventions

Cetuximab (CRC) DRUG

Cetuximab is administered in combination with induction chemotherapy followed by concurrent chemoradiotherapy, according to the study protocol.

Experimental arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Digestive System Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Klavdija Korošec

CONTACT

+386 31630065; kkorosec@onko-i.si

Neža Gros

CONTACT

ngros@onko-i.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group study assessing sarcopenia risk using the SARC-F screening tool at baseline and during systemic treatment.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start: October 24, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)