EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers (EAT-ING)
EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers: A Single-Center Randomized Trial
The use of immunomodulants in patients with GI cancer has been progressively gaining attention in the last years, as a high-calorie-high-protein nutritional blend enriched in immunonutrients has shown efficacy in several studies in reducing the risk of post-operative complications and the length of stay of patients undergoing major cancer surgery.
The guidelines for the nutritional management of patients with cancer agree on the utility of nutritional support, whenever it is necessary, to improve clinical outcomes, and the efficacy and tolerability of treatments.
To our knowledge, this is among the first clinical trial specifically designed to evaluate the role of immunomodulants-enriched ONS in combination with nutritional counseling in reducing serious AEs rate in patients with advanced GI cancers undergoing systemic treatments.
調査の概要
詳細な説明
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
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
説明
Inclusion Criteria:
- Will to participate by providing written IC.
- Male or female aged 18 years or older.
- A confirmed histological or radiological (in case of hepatocellular carcinoma) diagnosis of advanced GI cancer.
- Undergoing first-line systemic treatment for advanced disease as determined by the investigators, following good clinical practice and guidelines.
- Availability to take ONS.
- Patient's willingness to undergo blood draws to provide plasma and blood samples for analysis according to study objectives.
- An ECOG PS of 2 or less.
- Investigator's assessment of life expectancy ≥ 3 months.
Exclusion Criteria:
- Are under 18 years of age.
- Inability to sign an IC.
- Inability to follow the procedures of the study, e.g. due to language barrier, major psychological disorders, dementia, etc.;
- Indication to ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume ONS;
- Pregnancy or lactation.
研究計画
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：なし（オープンラベル）
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：LH BLU
Patients of interventional group will receive the immunomodulant LH BLU and nutritional counseling consisting of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences in order to achieve estimated protein-calorie requirements and taking into account chewing and swallowing abilities.
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LH BLU is a FSMP containing fats, carbohydrates, proteins and soluble fibers.
In addition, LH BLU contains L-Glutamine, carnosine, vitamin D3, zinc, selenium, fructooligosaccharide, inulin and botanical extracts.
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アクティブコンパレータ：ONS
Patients of interventional group will receive nutritional counseling consisting of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences in order to achieve estimated protein-calorie requirements and taking into account chewing and swallowing abilities.
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Patients of control group will receive nutritional counseling consisting of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences in order to achieve estimated protein-calorie requirements and taking into account chewing and swallowing abilities.
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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 |
|---|---|---|
|
Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs.
時間枠：From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
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Absolute risk difference between study arms in the incidence of grade ≥ 3 AEs, as defined by the Common Terminology Criteria for Adverse Events, version 5.0.
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。