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

26. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Brasilien
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30130-100
        • Rekruttering
        • School of Medicine, Federal University of Minas Gerais
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: HMB, hydroxymethylbutyrate
Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Andre navne:
  • β-hydroxy β-methylbutyrate
Placebo komparator: 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.
Kosttilskud: Maltodextrin (Placebo)
Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Andre navne:
  • Maltodextrin
  • Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and preoperative assessment
Serum CRP measured using ELISA, reported in mg/dL.
Baseline and preoperative assessment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skeletal Muscle Mass
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Federal University of Minas Gerais

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

30. november 2027

Datoer for studieregistrering

Først indsendt

30. september 2025

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 81288123400005149

Plan for individuelle deltagerdata (IPD)

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