Impact of Beta Hydroxy Methyl Butyrate (HMB) Supplementation on Inflammatory Markers and Clinical Outcomes in Patients With Head And Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
时间窗: 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
时间窗: Baseline and preoperative assessment.
Serum IL-1 levels measured using ELISA, reported in pg/mL.
Serum tumor necrosis factor alpha (TNF-α) concentration
时间窗: Baseline and preoperative assessment
Serum TNF-α levels measured using ELISA, reported in pg/mL.
Serum interleukin-10 (IL-10) concentration
时间窗: Baseline and preoperative assessment
Serum IL-10 levels measured using ELISA, reported in pg/mL.
Serum transforming growth factor beta (TGF-β) concentration
时间窗: Baseline and preoperative assessment
Serum TGF-β levels measured using ELISA, reported in pg/mL.
C-reactive protein (CRP) serum concentration
时间窗: Baseline and preoperative assessment
Serum CRP measured using ELISA, reported in mg/dL.
次要结局
- 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).)
- Mortality rate(From the day of surgery until hospital discharge (up to 60 days postoperatively))
- Tumor Proliferation Index(At the day of surgery, after approximately 30 days of supplementation)
研究者
Maria Isabel Toulson Davisson Correia
PhD
Federal University of Minas Gerais