RecruitingNot ApplicableNCT07404527

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


Sponsor

Institute of Oncology Ljubljana

Enrollment

60 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

Interventions

DRUGCetuximab (CRC)

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


Locations(1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

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NCT07404527


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