Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07404527

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

Led by Institute of Oncology Ljubljana · Updated on 2026-02-13

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Sarcopenia is a syndrome marked by progressive loss of muscle mass and strength, which negatively affects patients with cancer by worsening prognosis, increasing treatment side effects, and lowering quality of life. This study focuses on patients with gastrointestinal cancers, who are especially prone to sarcopenia due to the cancer itself and systemic anticancer treatments. Early detection of sarcopenia risk is crucial to provide timely nutritional and supportive care. Researchers will use the SARC-F questionnaire, a simple tool assessing muscle strength and function, to screen adult patients with gastrointestinal cancer before and during systemic anticancer therapy. Those who screen positive for sarcopenia risk will be referred for further clinical nutritional assessment and managed with individualized interventions by a multidisciplinary team. Treatment includes induction chemotherapy followed by chemoradiotherapy combined with cetuximab as per the study protocol. Participants will complete the SARC-F questionnaire at baseline and during treatment. Those at risk will undergo additional assessments such as body measurements and possibly DXA scans to evaluate muscle status more precisely. The study monitors outcomes including overall survival for up to five years, aiming to improve early identification and management of sarcopenia without adding extra diagnostic or therapeutic burden beyond standard care.

CONDITIONS

Brief Title

Bioelectrical Impedance Analysis for Perioperative Fluid Evaluation in Colorectal Cancer Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (18 years of age or older)
  • Histologically confirmed head and neck cancer
  • Indicated for induction chemotherapy followed by chemoradiotherapy with cetuximab
  • Adequate organ function as required by the study protocol
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Prior systemic therapy or radiotherapy for head and neck cancer
  • Presence of uncontrolled comorbidities that would prevent study treatment
  • Known allergy or hypersensitivity to cetuximab or treatment components
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of induction chemotherapy and concurrent chemoradiotherapy as per protocol

Participants receive induction chemotherapy followed by chemoradiotherapy with cetuximab according to the study protocol.

Multiple visits for treatment administration as per clinical schedule

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for overall survival and changes in sarcopenia risk during and after treatment, with assessments including the SARC-F questionnaire and clinical nutrition evaluations as part of routine care.

Assessments during treatment and follow-up visits as per clinical care

Trial Site Locations

Total: 1 location

1

Institute of Oncology Ljubljana

Ljubljana, Slovenia, 1000

Actively Recruiting

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Research Team

K

Klavdija Korošec

N

Neža Gros

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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