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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMB, hydroxymethylbutyrate | Dietary Supplement | Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and preoperative assessment |
| C-reactive protein (CRP) serum concentration | Serum CRP measured using ELISA, reported in mg/dL. | Baseline and preoperative assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and preoperative assessment (after 30 days of supplementation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcus Vinícius M Andrade, MD, PhD | Contact | +55 31 98805-3393 | andrademufmg@gmail.com | |
| Simone V Generoso, PhD | Contact | +55 31 988128650 | simonenutufmg@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcus Vinícius M Andrade, MD, PhD | Department of Medicine, Federal University of Minas Gerais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine, Federal University of Minas Gerais | Recruiting | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D007249 | Inflammation |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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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.
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| Maltodextrin (Placebo) | Dietary Supplement | Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery. |
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| Handgrip strength | Muscle strength assessed using a Jamar Smart Hand Dynamometer. | 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. | Baseline (first day of study inclusion) |
| Postoperative complications | Incidence of postoperative complications recorded according to medical records during hospitalization. | 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. | 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. | 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. | At the day of surgery, after approximately 30 days of supplementation |