Cancer patients undergoing surgery are at high risk of malnutrition due to the effects of the tumor and surgical stress, which can lead to worse clinical outcomes. This study aims to evaluate the impact of beta-hydroxy-beta-methylbutyrate (HMB) supplementation on inflammatory markers and clinical outcomes in patients with malignant tumors of the upper airways and digestive tract undergoing surgery.
This is a randomized, double-blind clinical trial. Participants will be randomly assigned to one of two groups: intervention (3 g/day of HMB) or control (3 g/day of maltodextrin) for 30 days prior to surgery. Initial assessments will include nutritional status, muscle strength, quadriceps muscle thickness by ultrasound, and laboratory tests. Postoperative clinical outcomes will be monitored through electronic medical records.
Individuals aged 18 years or older;
Both sexes (male and female);
Patients treated at the outpatient clinic for head and neck carcinoma;
Indication for potentially curative tumor resection surgery.
Diagnosis of cancer of the face, skin, paranasal sinuses, or thyroid;
Undergoing neoadjuvant or palliative treatment;
Cognitive or intellectual impairment that may hinder proper understanding of the study;
Refusal to participate or to sign the informed consent form.
Parallel
HMB, hydroxymethylbutyrate
Dietary supplementParticipants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Maltodextrin (Placebo)
Dietary supplementParticipants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
Serum IL-6 levels measured using enzyme-linked immunosorbent assay (ELISA), reported in picograms per milliliter (pg/mL). Blood samples will be collected at baseline and after 30 days of HMB supplementation (preoperative assessment).
Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration
Serum IL-1 levels measured using ELISA, reported in pg/mL.
Serum tumor necrosis factor alpha (TNF-α) concentration
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Serum interleukin-10 (IL-10) concentration
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Skeletal Muscle Mass
Muscle thickness of rectus femoris and vastus intermedius assessed by ultrasound using a linear transducer. Measurements will be taken at the midpoint between the iliac crest and the superior border of the patella, with the patient in a semi-recumbent position.
Handgrip strength
Muscle strength assessed using a Jamar Smart Hand Dynamometer.
Nutritional status assessed by Patient-Generated Subjective Global Assessment (PG-SGA)
Nutritional status assessed using the Patient-Generated Subjective Global Assessment (PG-SGA), with classification into well-nourished, moderately malnourished, or severely malnourished.
Postoperative complications
Incidence of postoperative complications recorded according to medical records during hospitalization.
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