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NCT Number: NCT07675421

Impact of HMB Supplementation on Inflammation and Outcomes in 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.

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Key information

Conditions

Head and Neck Cancers Head and Neck Neoplasms Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location status: Recruiting

Location contact

Simone V Generoso, PhD

CONTACT

[email protected]

55(31) 98812-8650

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HMB, hydroxymethylbutyrate

Dietary Supplement

Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.

Other names: β-hydroxy β-methylbutyrate

Maltodextrin (Placebo)

Dietary Supplement

Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.

Other names: Maltodextrin, Placebo

Primary outcomes

  1. Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio

    Time frame: 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).

  2. Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration

    Time frame: Baseline and preoperative assessment.

    Serum IL-1 levels measured using ELISA, reported in pg/mL.

  3. Serum tumor necrosis factor alpha (TNF-α) concentration

    Time frame: Baseline and preoperative assessment

    Serum TNF-α levels measured using ELISA, reported in pg/mL.

  4. Serum interleukin-10 (IL-10) concentration

    Time frame: Baseline and preoperative assessment

    Serum IL-10 levels measured using ELISA, reported in pg/mL.

  5. Serum transforming growth factor beta (TGF-β) concentration

    Time frame: Baseline and preoperative assessment

    Serum TGF-β levels measured using ELISA, reported in pg/mL.

  6. C-reactive protein (CRP) serum concentration

    Time frame: Baseline and preoperative assessment

    Serum CRP measured using ELISA, reported in mg/dL.

Secondary outcomes

  1. Skeletal Muscle Mass

    Time frame: 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.

  2. Handgrip strength

    Time frame: 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.

  3. Nutritional status assessed by Patient-Generated Subjective Global Assessment (PG-SGA)

    Time frame: 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.

  4. Postoperative complications

    Time frame: 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.

  5. Length of hospital stay

    Time frame: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).

    Number of days from surgery to hospital discharge.

  6. Mortality rate

    Time frame: From the day of surgery until hospital discharge (up to 60 days postoperatively)

    All-cause mortality during hospitalization or within 30 days after surgery.

  7. Tumor Proliferation Index

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcus Vinícius M Andrade, MD, PhD

CONTACT

[email protected]

+55 31 98805-3393

Simone V Generoso, PhD

CONTACT

[email protected]

+55 31 988128650

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

Impact of Beta Hydroxy Methyl Butyrate (HMB) Supplementation on Inflammatory Markers and Clinical Outcomes in Patients With Head And Neck Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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