Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer

Impact of Beta Hydroxy Methyl Butyrate (HMB) Supplementation on Inflammatory Markers and Clinical Outcomes in Patients With Head And Neck Cancer

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 Overview

• Status: Recruiting
• Conditions: Head and Neck Cancers
• Intervention / Treatment: Dietary supplement: HMB, hydroxymethylbutyrate; Dietary supplement: Maltodextrin (Placebo)

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcus Vinícius M Andrade, MD, PhD; Phone Number: +55 31 98805-3393; Email: andrademufmg@gmail.com
• Study Contact Backup: Name: Simone V Generoso, PhD; Phone Number: +55 31 988128650; Email: simonenutufmg@gmail.com

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Recruiting
      • School of Medicine, Federal University of Minas Gerais
      • Contact: Simone V Generoso, PhD; Phone Number: 55(31) 98812-8650; Email: simonenutufmg@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HMB group; Participants in the intervention group will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery. The supplementation is intended to support nutritional status, muscle mass preservation, and improve preoperative outcomes.	Dietary supplement: HMB, hydroxymethylbutyrate; Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.; Other Names: β-hydroxy β-methylbutyrate
Placebo Comparator: Control group; Participants in the control group will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery. The placebo is identical in appearance and dosage to the intervention supplement but does not contain the active ingredient.	Dietary supplement: Maltodextrin (Placebo); Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.; Other Names: Maltodextrin; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Baseline and preoperative assessment.
Serum tumor necrosis factor alpha (TNF-α) concentration	Serum TNF-α levels measured using ELISA, reported in pg/mL.	Baseline and preoperative assessment
Serum interleukin-10 (IL-10) concentration	Serum IL-10 levels measured using ELISA, reported in pg/mL.	Baseline and preoperative assessment
Serum transforming growth factor beta (TGF-β) concentration	Serum TGF-β levels measured using ELISA, reported in pg/mL.	Baseline and preoperative assessment
C-reactive protein (CRP) serum concentration	Serum CRP measured using ELISA, reported in mg/dL.	Baseline and preoperative assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and preoperative assessment (after 30 days of supplementation)
Handgrip strength	Muscle strength assessed using a Jamar Smart Hand Dynamometer.	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.	Baseline (first day of study inclusion)
Postoperative complications	Incidence of postoperative complications recorded according to medical records during hospitalization.	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.	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.	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.	At the day of surgery, after approximately 30 days of supplementation

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Marcus Vinícius M Andrade, MD, PhD, Department of Medicine, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Surgery; Head and Neck Neoplasms; Postoperative Complications; Muscle Mass
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Pathological Conditions, Signs and Symptoms; Inflammation; Head and Neck Neoplasms; Postoperative Complications; maltodextrin
• Other Study ID Numbers: 81288123400005149

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No