Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer
26 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
66
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Marcus Vinícius M Andrade, MD, PhD
- Numéro de téléphone: +55 31 98805-3393
- E-mail: andrademufmg@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Simone V Generoso, PhD
- Numéro de téléphone: +55 31 988128650
- E-mail: simonenutufmg@gmail.com
Lieux d'étude
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brésil, 30130-100
- Recrutement
- School of Medicine, Federal University of Minas Gerais
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Contact:
- Simone V Generoso, PhD
- Numéro de téléphone: 55(31) 98812-8650
- E-mail: simonenutufmg@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Autres noms:
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Comparateur placebo: 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.
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Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
Délai: Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
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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).
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Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
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Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration
Délai: Baseline and preoperative assessment.
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Serum IL-1 levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment.
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Serum tumor necrosis factor alpha (TNF-α) concentration
Délai: Baseline and preoperative assessment
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Serum TNF-α levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment
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Serum interleukin-10 (IL-10) concentration
Délai: Baseline and preoperative assessment
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Serum IL-10 levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment
|
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Serum transforming growth factor beta (TGF-β) concentration
Délai: Baseline and preoperative assessment
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Serum TGF-β levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment
|
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C-reactive protein (CRP) serum concentration
Délai: Baseline and preoperative assessment
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Serum CRP measured using ELISA, reported in mg/dL.
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Baseline and preoperative assessment
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Skeletal Muscle Mass
Délai: Baseline and preoperative assessment (after 30 days of supplementation)
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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.
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Baseline and preoperative assessment (after 30 days of supplementation)
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Handgrip strength
Délai: Baseline (first day of study inclusion) and preoperative assessment (day of surgery, after 30 days of supplementation)
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Muscle strength assessed using a Jamar Smart Hand Dynamometer.
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Baseline (first day of study inclusion) and preoperative assessment (day of surgery, after 30 days of supplementation)
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Nutritional status assessed by Patient-Generated Subjective Global Assessment (PG-SGA)
Délai: Baseline (first day of study inclusion)
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Nutritional status assessed using the Patient-Generated Subjective Global Assessment (PG-SGA), with classification into well-nourished, moderately malnourished, or severely malnourished.
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Baseline (first day of study inclusion)
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Postoperative complications
Délai: From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
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Incidence of postoperative complications recorded according to medical records during hospitalization.
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From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
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Length of hospital stay
Délai: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
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Number of days from surgery to hospital discharge.
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Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
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Mortality rate
Délai: From the day of surgery until hospital discharge (up to 60 days postoperatively)
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All-cause mortality during hospitalization or within 30 days after surgery.
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From the day of surgery until hospital discharge (up to 60 days postoperatively)
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Tumor Proliferation Index
Délai: At the day of surgery, after approximately 30 days of supplementation
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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.
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At the day of surgery, after approximately 30 days of supplementation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Marcus Vinícius M Andrade, MD, PhD, Department of Medicine, Federal University of Minas Gerais
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 août 2027
Achèvement de l'étude (Estimé)
30 novembre 2027
Dates d'inscription aux études
Première soumission
30 septembre 2025
Première soumission répondant aux critères de contrôle qualité
26 juin 2026
Première publication (Réel)
30 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
30 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2026
Dernière vérification
1 mars 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 81288123400005149
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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