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Recruiting NCT07675421

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

No phase Interventional Head and Neck Cancers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HMB, hydroxymethylbutyrate, Maltodextrin (Placebo).
Who it may be relevant to
Registry conditions: Head and Neck Cancers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement HMB, hydroxymethylbutyrate
    Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
  • Dietary supplement Maltodextrin (Placebo)
    Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.

Primary outcome measures

  • 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)]
  • Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration [Time frame: Baseline and preoperative assessment.]
  • Serum tumor necrosis factor alpha (TNF-α) concentration [Time frame: Baseline and preoperative assessment]
  • Serum interleukin-10 (IL-10) concentration [Time frame: Baseline and preoperative assessment]
  • Serum transforming growth factor beta (TGF-β) concentration [Time frame: Baseline and preoperative assessment]
  • C-reactive protein (CRP) serum concentration [Time frame: Baseline and preoperative assessment]
Secondary outcome measures (7)
  • Skeletal Muscle Mass [Time frame: Baseline and preoperative assessment (after 30 days of supplementation)]
  • Handgrip strength [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) [Time frame: Baseline (first day of study inclusion)]
  • Postoperative complications [Time frame: From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)]
  • Length of hospital stay [Time frame: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).]
  • Mortality rate [Time frame: From the day of surgery until hospital discharge (up to 60 days postoperatively)]
  • Tumor Proliferation Index [Time frame: At the day of surgery, after approximately 30 days of supplementation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Supportive care

Study locations

Brazil · 1 center
  • School of Medicine, Federal University of Minas Gerais — Belo Horizonte

Identifiers

NCT: NCT07675421 · 81288123400005149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗