HMB, hydroxymethylbutyrate: Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Maltodextrin (Placebo): Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio — Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery) 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 — Baseline and preoperative assessment. Serum IL-1 levels measured using ELISA, reported in pg/mL.
Serum tumor necrosis factor alpha (TNF-α) concentration — Baseline and preoperative assessment Serum TNF-α levels measured using ELISA, reported in pg/mL.
Serum interleukin-10 (IL-10) concentration — Baseline and preoperative assessment Serum IL-10 levels measured using ELISA, reported in pg/mL.
Serum transforming growth factor beta (TGF-β) concentration — Baseline and preoperative assessment Serum TGF-β levels measured using ELISA, reported in pg/mL.
C-reactive protein (CRP) serum concentration — Baseline and preoperative assessment Serum CRP measured using ELISA, reported in mg/dL.
Trial sites (1)
Facility
City
Region
Status
School of Medicine, Federal University of Minas Gerais
Belo Horizonte
Minas Gerais
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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