RecruitingNot Applicable

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

Brazil66 participantsStarted 2026-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio

Timeframe: Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)

Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration

Timeframe: Baseline and preoperative assessment.

Serum tumor necrosis factor alpha (TNF-α) concentration

Timeframe: Baseline and preoperative assessment

Serum interleukin-10 (IL-10) concentration

Timeframe: Baseline and preoperative assessment

Serum transforming growth factor beta (TGF-β) concentration

Timeframe: Baseline and preoperative assessment

C-reactive protein (CRP) serum concentration

Timeframe: Baseline and preoperative assessment

Trial details

NCT IDNCT07675421

SponsorFederal University of Minas Gerais

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

Contact for this trial

Marcus Vinícius M Andrade, MD, PhD

+55 31 98805-3393 andrademufmg@gmail.com

View on ClinicalTrials.gov More Head and Neck Cancers trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio

Timeframe: Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)

Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration

Timeframe: Baseline and preoperative assessment.

Serum tumor necrosis factor alpha (TNF-α) concentration

Timeframe: Baseline and preoperative assessment

Serum interleukin-10 (IL-10) concentration

Timeframe: Baseline and preoperative assessment

Serum transforming growth factor beta (TGF-β) concentration

Timeframe: Baseline and preoperative assessment

C-reactive protein (CRP) serum concentration

Timeframe: Baseline and preoperative assessment