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Outcome Measures

Primary Outcomes (6)

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).
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.
Baseline and preoperative assessment.
Serum tumor necrosis factor alpha (TNF-α) concentration
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Baseline and preoperative assessment
Serum interleukin-10 (IL-10) concentration
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Baseline and preoperative assessment
Serum transforming growth factor beta (TGF-β) concentration
Serum TGF-β levels measured using ELISA, reported in pg/mL.

Secondary Outcomes (7)

Skeletal Muscle Mass
Baseline and preoperative assessment (after 30 days of supplementation)
Handgrip strength
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)
Baseline (first day of study inclusion)
Postoperative complications
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 the first postoperative day until hospital discharge (up to 60 days postoperatively).
+2 more secondary outcomes

Study Arms (2)

HMB group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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)

Interventions

HMB, hydroxymethylbutyrateDietary supplement

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

HMB group

Maltodextrin (Placebo)Dietary supplement

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

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Purpose

SUPPORTIVE CARE

Intervention Model

PARALLEL

Model Details: Patients will be randomly allocated into two groups using block randomization: the intervention group (patients who will receive HMB) or the control group (patients who will receive a control supplement). Both groups will receive, once daily, one sachet containing either 3 g/day of HMB (intervention) or 3 g/day of maltodextrin (control) for 30 days prior to the surgical procedure. Randomization will be performed using two blocks, each containing 33 participants, with each participant randomly assigned to treatment A or B. Both the principal investigator and the study participants will be blinded to the treatment allocation (A or B). A third party, who will not be involved in any stage of the clinical follow-up of the patients, will have access to the randomization list.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

PhD

Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer

Brief Summary

Registry Overview

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Study Timeline

First Submitted

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Study Start

Primary Completion

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Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (7)

Study Arms (2)

HMB group

Control group

Interventions

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Study Sites (1)

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Interventions

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Central Study Contacts

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Source record

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Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (7)

Study Arms (2)

HMB group

Control group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations