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

26 juni 2026 bijgewerkt door: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

66

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Brazilië
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazilië, 30130-100
        • Werving
        • School of Medicine, Federal University of Minas Gerais
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Voedingssupplement: HMB, hydroxymethylbutyrate
Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Andere namen:
  • β-hydroxy β-methylbutyrate
Placebo-vergelijker: 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.
Voedingssupplement: Maltodextrin (Placebo)
Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Andere namen:
  • Maltodextrine
  • Placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
Tijdsspanne: 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).
Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration
Tijdsspanne: Baseline and preoperative assessment.
Serum IL-1 levels measured using ELISA, reported in pg/mL.
Baseline and preoperative assessment.
Serum tumor necrosis factor alpha (TNF-α) concentration
Tijdsspanne: Baseline and preoperative assessment
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Baseline and preoperative assessment
Serum interleukin-10 (IL-10) concentration
Tijdsspanne: Baseline and preoperative assessment
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Baseline and preoperative assessment
Serum transforming growth factor beta (TGF-β) concentration
Tijdsspanne: Baseline and preoperative assessment
Serum TGF-β levels measured using ELISA, reported in pg/mL.
Baseline and preoperative assessment
C-reactive protein (CRP) serum concentration
Tijdsspanne: Baseline and preoperative assessment
Serum CRP measured using ELISA, reported in mg/dL.
Baseline and preoperative assessment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Skeletal Muscle Mass
Tijdsspanne: Baseline and preoperative assessment (after 30 days of supplementation)
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
Tijdsspanne: Baseline (first day of study inclusion) and preoperative assessment (day of surgery, after 30 days of supplementation)
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)
Tijdsspanne: Baseline (first day of study inclusion)
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
Tijdsspanne: From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
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
Tijdsspanne: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
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
Tijdsspanne: From the day of surgery until hospital discharge (up to 60 days postoperatively)
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
Tijdsspanne: At the day of surgery, after approximately 30 days of supplementation
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Federal University of Minas Gerais

Onderzoekers

  • Hoofdonderzoeker: Marcus Vinícius M Andrade, MD, PhD, Department of Medicine, Federal University of Minas Gerais

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

30 november 2027

Studieregistratiedata

Eerst ingediend

30 september 2025

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

30 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 81288123400005149

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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