An interventional study of HMB, hydroxymethylbutyrate and Maltodextrin (Placebo) in Head and Neck Cancers, sponsored by Federal University of Minas Gerais. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Supportive care
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 66 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Federal University of Minas Gerais is the lead sponsor of 152 studies on the registry; 18 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: HMB, hydroxymethylbutyrate
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.
Dietary Supplement: Maltodextrin (Placebo)
Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
Also known as: β-hydroxy β-methylbutyrate
Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Also known as: Maltodextrin, Placebo
Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
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).
Time frame: Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration
Serum IL-1 levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment.
Serum tumor necrosis factor alpha (TNF-α) concentration
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment
Serum interleukin-10 (IL-10) concentration
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment
Serum transforming growth factor beta (TGF-β) concentration
Serum TGF-β levels measured using ELISA, reported in pg/mL.
Time frame: Baseline and preoperative assessment
C-reactive protein (CRP) serum concentration
Serum CRP measured using ELISA, reported in mg/dL.
Time frame: Baseline and preoperative assessment
Skeletal Muscle Mass
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.
Time frame: Baseline and preoperative assessment (after 30 days of supplementation)
Handgrip strength
Muscle strength assessed using a Jamar Smart Hand Dynamometer.
Time frame: 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)
Nutritional status assessed using the Patient-Generated Subjective Global Assessment (PG-SGA), with classification into well-nourished, moderately malnourished, or severely malnourished.
Time frame: Baseline (first day of study inclusion)
Postoperative complications
Incidence of postoperative complications recorded according to medical records during hospitalization.
Time frame: From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
Length of hospital stay
Number of days from surgery to hospital discharge.
Time frame: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
Mortality rate
All-cause mortality during hospitalization or within 30 days after surgery.
Time frame: From the day of surgery until hospital discharge (up to 60 days postoperatively)
Tumor Proliferation Index
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.
Time frame: At the day of surgery, after approximately 30 days of supplementation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Aug 2027, 12 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 12 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
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