Head and Neck Cancers
Conditions
Keywords
Head and Neck Neoplasms, Surgery, Inflammation, Muscle Mass, Postoperative Complications
Brief summary
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_SUPPLEMENTHMB, hydroxymethylbutyrate
Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
DIETARY_SUPPLEMENTMaltodextrin (Placebo)
Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio | 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). |
| Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration | Baseline and preoperative assessment. | Serum IL-1 levels measured using ELISA, reported in pg/mL. |
| Serum tumor necrosis factor alpha (TNF-α) concentration | Baseline and preoperative assessment | Serum TNF-α levels measured using ELISA, reported in pg/mL. |
| Serum interleukin-10 (IL-10) concentration | Baseline and preoperative assessment | Serum IL-10 levels measured using ELISA, reported in pg/mL. |
| Serum transforming growth factor beta (TGF-β) concentration | Baseline and preoperative assessment | Serum TGF-β levels measured using ELISA, reported in pg/mL. |
| C-reactive protein (CRP) serum concentration | Baseline and preoperative assessment | Serum CRP measured using ELISA, reported in mg/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal Muscle Mass | 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. |
| Handgrip strength | 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. |
| Nutritional status assessed by Patient-Generated Subjective Global Assessment (PG-SGA) | 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. |
| Postoperative complications | 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. |
| Length of hospital stay | Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively). | Number of days from surgery to hospital discharge. |
| Mortality rate | From the day of surgery until hospital discharge (up to 60 days postoperatively) | All-cause mortality during hospitalization or within 30 days after surgery. |
| Tumor Proliferation Index | 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. |
Countries
Brazil
Contacts
CONTACTMarcus Vinícius M Andrade, MD, PhD
CONTACTSimone V Generoso, PhD
PRINCIPAL_INVESTIGATORMarcus Vinícius M Andrade, MD, PhD
Department of Medicine, Federal University of Minas Gerais
Outcome results
None listed