Abstract 931TiP
Background
Patients with squamous cell carcinoma of the head and neck (SCCHN) present with a severe risk of malnutrition, which is related to tumor location, catabolic status of the disease, treatment toxicity and sociocultural background. Treatment of locally advanced SCCHN, with concurrent chemoradiotherapy (CCRT) is associated with local and systemic toxicity leading to weight loss and malnutrition. Although malnutrition is a global concern linked to morbidity, mortality and high healthcare related costs, the diagnostic criteria for this condition and their application on the clinical setting are not consensual. Hitherto there is no recommended guideline on how to evaluate the nutritional status of these patients. In 2018, as an attempt to standardize this evaluation, the “Global Leadership Initiative on Malnutrition” (GLIM) published a consensus report for diagnosing malnutrition in adults in clinical settings on a global scale. However, so far, few studies have applied the GLIM criteria for the diagnosis of malnutrition in patients with SCCHN, and none investigated the association between malnutrition applying the GLIM criteria and response to treatment.
Trial design
Prospective single-center cohort study, which includes patients with SCCHN located in the oral cavity, oropharynx, hypopharynx or larynx, being treated with CCRT, with curative intention. Sixty patients with SCCHN will be enrolled with the primary objective being evaluation of the connection between malnutrition applying the GLIM criteria and response to treatment. To diagnose malnutrition at least one phenotypic criterion and one etiologic criterion should be present. The phenotypic criteria are: ≥5% unintentional loss of body weight, body mass index and reduced muscle mass (scored by Patient-Generated Subjective Global Assessment - PG-SGA). The etiologic criteria are: reduced food intake or assimilation and c-reactive protein >5mg/dL as inflammation marker. The GLIM criteria for malnutrition will be applied previously at day one (D1) of therapy and between day forty-two (D42) and the last day of therapy. The selection process of this study began in January 2021 and is currently ongoing.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
M.J.P. de Sousa.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.