Clinical trial · Interventional
Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer
Impact of Beta Hydroxy Methyl Butyrate (HMB) Supplementation on Inflammatory Markers and Clinical Outcomes in Patients With Head And Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancers | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMB, hydroxymethylbutyrate | Dietary Supplement | — | UNRESOLVED |
| Maltodextrin (Placebo) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HMB group
- description
- 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.
- interventionNames
- Dietary Supplement: HMB, hydroxymethylbutyrate
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- 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.
- interventionNames
- Dietary Supplement: Maltodextrin (Placebo)
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available