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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
66
Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
School of Medicine, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
RECRUITINGInflammatory 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).
Time frame: Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration
Serum IL-1 levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment.
Serum tumor necrosis factor alpha (TNF-α) concentration
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment
Serum interleukin-10 (IL-10) concentration
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment
Serum transforming growth factor beta (TGF-β) concentration
Serum TGF-β levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment
C-reactive protein (CRP) serum concentration
Serum CRP measured using ELISA, reported in mg/dL.
Time frame: Baseline and preoperative assessment
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.
Time frame: Baseline and preoperative assessment (after 30 days of supplementation)
Handgrip strength
Muscle strength assessed using a Jamar Smart Hand Dynamometer.
Time frame: Baseline (first day of study inclusion) and preoperative assessment (day of surgery, after 30 days of supplementation)
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.
Time frame: Baseline (first day of study inclusion)
Postoperative complications
Incidence of postoperative complications recorded according to medical records during hospitalization.
Time frame: From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
Length of hospital stay
Number of days from surgery to hospital discharge.
Time frame: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
Mortality rate
All-cause mortality during hospitalization or within 30 days after surgery.
Time frame: From the day of surgery until hospital discharge (up to 60 days postoperatively)
Tumor Proliferation Index
During the surgical procedure, a 2 cm fragment of tumor tissue will be collected by the surgical team. The sample will be stored in Eppendorf microtubes containing RNAlater solution and buffered formalin at room temperature. Subsequently, the tissue will be processed and prepared for analysis. These analyses will aim to evaluate the impact of HMB supplementation on tumor proliferation in patients undergoing surgery for malignant neoplasms of the upper aerodigestive tract.
Time frame: At the day of surgery, after approximately 30 days of supplementation
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