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

NCT07675421 | Recruiting DMC

• 1 other identifier: 81288123400005149
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancers

Keywords

Head and Neck Neoplasms; Surgery; Inflammation; Muscle Mass; Postoperative Complications

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Skeletal Muscle Mass

  Baseline and preoperative assessment (after 30 days of supplementation)

• Handgrip strength

  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)

  Baseline (first day of study inclusion)

• Postoperative complications

  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 the first postoperative day until hospital discharge (up to 60 days postoperatively).

Study Arms (2)

HMB group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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)

Interventions

HMB, hydroxymethylbutyrate DIETARY_SUPPLEMENT

Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.

Also known as: β-hydroxy β-methylbutyrate

HMB group

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.

Also known as: Maltodextrin, Placebo

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

School of Medicine, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Inflammation; Postoperative Complications

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcus Vinícius M Andrade, MD, PhD

  Department of Medicine, Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Vinícius M Andrade, MD, PhD

CONTACT

+55 31 98805-3393; andrademufmg@gmail.com

Simone V Generoso, PhD

CONTACT

+55 31 988128650; simonenutufmg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Patients will be randomly allocated into two groups using block randomization: the intervention group (patients who will receive HMB) or the control group (patients who will receive a control supplement). Both groups will receive, once daily, one sachet containing either 3 g/day of HMB (intervention) or 3 g/day of maltodextrin (control) for 30 days prior to the surgical procedure. Randomization will be performed using two blocks, each containing 33 participants, with each participant randomly assigned to treatment A or B. Both the principal investigator and the study participants will be blinded to the treatment allocation (A or B). A third party, who will not be involved in any stage of the clinical follow-up of the patients, will have access to the randomization list.

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: June 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)