Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer
2026년 6월 26일 업데이트: Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
Impact of Beta Hydroxy Methyl Butyrate (HMB) Supplementation on Inflammatory Markers and Clinical Outcomes in Patients With Head And Neck Cancer
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.
연구 개요
연구 유형
중재적
등록 (추정된)
66
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Marcus Vinícius M Andrade, MD, PhD
- 전화번호: +55 31 98805-3393
- 이메일: andrademufmg@gmail.com
연구 연락처 백업
- 이름: Simone V Generoso, PhD
- 전화번호: +55 31 988128650
- 이메일: simonenutufmg@gmail.com
연구 장소
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Minas Gerais
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Belo Horizonte, Minas Gerais, 브라질, 30130-100
- 모병
- School of Medicine, Federal University of Minas Gerais
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연락하다:
- Simone V Generoso, PhD
- 전화번호: 55(31) 98812-8650
- 이메일: simonenutufmg@gmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: HMB group
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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Participants will receive one sachet per day containing 3 g of β-hydroxy β-methylbutyrate (HMB) for 30 days prior to surgery.
다른 이름들:
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위약 비교기: Control group
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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Participants will receive one sachet per day containing 3 g of maltodextrin (placebo) for 30 days prior to surgery.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
기간: Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
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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).
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Baseline (Day 0) and preoperative assessment (after 30 days of supplementation) (preoperative assessment, immediately before surgery)
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Inflammatory Biomarkers: Serum interleukin-1 (IL-1) concentration
기간: Baseline and preoperative assessment.
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Serum IL-1 levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment.
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Serum tumor necrosis factor alpha (TNF-α) concentration
기간: Baseline and preoperative assessment
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Serum TNF-α levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment
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Serum interleukin-10 (IL-10) concentration
기간: Baseline and preoperative assessment
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Serum IL-10 levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment
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Serum transforming growth factor beta (TGF-β) concentration
기간: Baseline and preoperative assessment
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Serum TGF-β levels measured using ELISA, reported in pg/mL.
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Baseline and preoperative assessment
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C-reactive protein (CRP) serum concentration
기간: Baseline and preoperative assessment
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Serum CRP measured using ELISA, reported in mg/dL.
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Baseline and preoperative assessment
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Skeletal Muscle Mass
기간: Baseline and preoperative assessment (after 30 days of supplementation)
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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.
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Baseline and preoperative assessment (after 30 days of supplementation)
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Handgrip strength
기간: Baseline (first day of study inclusion) and preoperative assessment (day of surgery, after 30 days of supplementation)
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Muscle strength assessed using a Jamar Smart Hand Dynamometer.
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Baseline (first day of study inclusion) and preoperative assessment (day of surgery, after 30 days of supplementation)
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Nutritional status assessed by Patient-Generated Subjective Global Assessment (PG-SGA)
기간: Baseline (first day of study inclusion)
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Nutritional status assessed using the Patient-Generated Subjective Global Assessment (PG-SGA), with classification into well-nourished, moderately malnourished, or severely malnourished.
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Baseline (first day of study inclusion)
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Postoperative complications
기간: From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
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Incidence of postoperative complications recorded according to medical records during hospitalization.
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From the first postoperative day until hospital discharge or death (varied duration; expected up to 60 days)
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Length of hospital stay
기간: Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
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Number of days from surgery to hospital discharge.
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Number of days from the first postoperative day until hospital discharge (up to 60 days postoperatively).
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Mortality rate
기간: From the day of surgery until hospital discharge (up to 60 days postoperatively)
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All-cause mortality during hospitalization or within 30 days after surgery.
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From the day of surgery until hospital discharge (up to 60 days postoperatively)
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Tumor Proliferation Index
기간: At the day of surgery, after approximately 30 days of supplementation
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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.
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At the day of surgery, after approximately 30 days of supplementation
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Marcus Vinícius M Andrade, MD, PhD, Department of Medicine, Federal University of Minas Gerais
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2027년 8월 31일
연구 완료 (추정된)
2027년 11월 30일
연구 등록 날짜
최초 제출
2025년 9월 30일
QC 기준을 충족하는 최초 제출
2026년 6월 26일
처음 게시됨 (실제)
2026년 6월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 26일
마지막으로 확인됨
2026년 3월 1일
추가 정보
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