Head and Neck CancersNCT07675421
Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer
A study testing HMB, hydroxymethylbutyrate in people with Head and Neck Cancers, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- HMB, hydroxymethylbutyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2026to 30 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
School of Medicine, Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100
Simone V Generoso, PhD, 55(31) 98812-8650, simonenutufmg@gmail.com
About this study
Official title: 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.
- Conditions
- Head and Neck Cancers
- Being tested
- HMB, hydroxymethylbutyrate, Maltodextrin (Placebo)
- Keywords
- Head and Neck Neoplasms, Surgery, Inflammation, Muscle Mass, Postoperative Complications
- Medical subject headings
- Head and Neck Neoplasms, Inflammation, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMB, hydroxymethylbutyrateDietary supplement
Also called β-hydroxy β-methylbutyrate
Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Maltodextrin (Placebo)Dietary supplement
Also called Maltodextrin, Placebo
Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline and preoperative assessment.
Serum tumor necrosis factor alpha (TNF-α) concentration
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Measured: Baseline and preoperative assessment
Serum interleukin-10 (IL-10) concentration
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Measured: Baseline and preoperative assessment
Serum transforming growth factor beta (TGF-β) concentration
Serum TGF-β levels measured using ELISA, reported in pg/mL.
Measured: Baseline and preoperative assessment
C-reactive protein (CRP) serum concentration
Serum CRP measured using ELISA, reported in mg/dL.
Measured: Baseline and preoperative assessment
Secondary outcomes (7)
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.
Measured: Baseline and preoperative assessment (after 30 days of supplementation)
Handgrip strength
Muscle strength assessed using a Jamar Smart Hand Dynamometer.
Measured: 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.
Measured: Baseline (first day of study inclusion)
Postoperative complications
Incidence of postoperative complications recorded according to medical records during hospitalization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the day of surgery, after approximately 30 days of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Marcus Vinícius M Andrade, MD, PhD, Principal investigator, Department of Medicine, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675421
- Sponsor's protocol ID
- 81288123400005149
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No