Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer
26 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
66
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Marcus Vinícius M Andrade, MD, PhD
- Número de teléfono: +55 31 98805-3393
- Correo electrónico: andrademufmg@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Simone V Generoso, PhD
- Número de teléfono: +55 31 988128650
- Correo electrónico: simonenutufmg@gmail.com
Ubicaciones de estudio
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30130-100
- Reclutamiento
- School of Medicine, Federal University of Minas Gerais
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Contacto:
- Simone V Generoso, PhD
- Número de teléfono: 55(31) 98812-8650
- Correo electrónico: simonenutufmg@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
Otros nombres:
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Comparador de placebos: 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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skeletal Muscle Mass
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Marcus Vinícius M Andrade, MD, PhD, Department of Medicine, Federal University of Minas Gerais
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
31 de agosto de 2027
Finalización del estudio (Estimado)
30 de noviembre de 2027
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2025
Primero enviado que cumplió con los criterios de control de calidad
26 de junio de 2026
Publicado por primera vez (Actual)
30 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de junio de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 81288123400005149
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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