Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer
2026年6月26日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
66
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Marcus Vinícius M Andrade, MD, PhD
- 電話番号：+55 31 98805-3393
- メール：andrademufmg@gmail.com
研究連絡先のバックアップ
- 名前：Simone V Generoso, PhD
- 電話番号：+55 31 988128650
- メール：simonenutufmg@gmail.com
研究場所
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Minas Gerais
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Belo Horizonte、Minas Gerais、ブラジル、30130-100
- 募集
- School of Medicine, Federal University of Minas Gerais
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コンタクト：
- Simone V Generoso, PhD
- 電話番号：55(31) 98812-8650
- メール：simonenutufmg@gmail.com
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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プラセボコンパレーター：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Inflammatory Biomarkers: Serum interleukin-6 (IL-6) concentratio
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Skeletal Muscle Mass
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Marcus Vinícius M Andrade, MD, PhD、Department of Medicine, Federal University of Minas Gerais
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2027年8月31日
研究の完了 (推定)
2027年11月30日
試験登録日
最初に提出
2025年9月30日
QC基準を満たした最初の提出物
2026年6月26日
最初の投稿 (実際)
2026年6月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月30日
QC基準を満たした最後の更新が送信されました
2026年6月26日
最終確認日
2026年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。