転移性非小細胞肺癌患者における免疫療法の有効性を改善するための免疫栄養 (MURAL)
体系的な栄養カウンセリングを受けている転移性非小細胞肺癌患者の免疫療法の有効性を改善する際の免疫栄養を評価するための多施設、無作為化、非盲検、並行群間試験
The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Riccardo Caccialanza, MD
- 電話番号：0039 0382501615
- メール：r.caccialanza@smatteo.pv.it
研究連絡先のバックアップ
- 名前：Alessandra Ferrari, PharmD
- 電話番号：0039 0382503689
- メール：alessandra.ferrari@smatteo.pv.it
研究場所
-
-
-
Pavia、イタリア
- 募集
- Fondazione IRCCS Policlinico San Matteo
-
コンタクト：
- Riccardo Caccialanza, MD
- 電話番号：+390382501615
- メール：r.caccialanza@smatteo.pv.it
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Confirmed histological diagnosis of metastatic non-small cell lung cancer (both squamous and non-squamous histology);
- First-line treatment with immunotherapy (alone or in combination with chemotherapy) for metastatic disease by investigators' choice within the framework of good clinical practice and in agreement with current guidelines;
- Will to participate by providing written informed consent;
- Availability to administer oral supplements and immunotherapy with or without chemotherapy;
- Eastern Cooperative Oncology Group Performance Status ≤ 2;
- Life expectancy ≥ 6 months.
Exclusion Criteria:
- Age < 18 years;
- Inability to sign an informed consent;
- Indication to or ongoing artificial nutrition support (totally compromised spontaneous food-intake) and incapacity or unavailability to consume oral nutritional supplements
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：処理
- 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 |
|---|---|
|
実験的：Immunonutrition
In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs |
In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Oral Impact®). The intervention will start approximately two weeks before anticancer treatment initiation and will continue up to first disease re-assessment (12-14 weeks) and prolonged according to patient's needs |
|
アクティブコンパレータ：Control dietary intervention
Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake. |
Patients will receive nutritional counseling as standard of care. Nutritional counseling may comprise the use of oral nutritional supplements (ONS), which are usually prescribed when patients are unable to maintain satisfactory spontaneous food intake (less than 50% of the requirement for more than one week or only 50-75% of the requirement for more than two weeks). Therefore, in this arm the use of isonitrogenous standard blend ONS will be considered according to the regular assessment of food intake. |
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 |
|---|---|---|
|
Progression-Free Survival (PFS)
時間枠：12 months
|
A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months. |
12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：24 months
|
Overall survival |
24 months
|
|
Duration of response
時間枠：24 months
|
Time to progression |
24 months
|
|
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
時間枠：4 months
|
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0 |
4 months
|
|
Skeletal muscle mass
時間枠：12 months
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans |
12 months
|
|
Fatigue
時間枠：12 months
|
Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire |
12 months
|
|
Self-perceived quality of life
時間枠：12 months
|
Change in quality of life during the study as assessed by validated questionnaires |
12 months
|
|
Self-reported physical activity level
時間枠：12 months
|
Change in self-reported physical activity level as assessed by the Godin's Shepard Leisure Time Exercise Questionnaire |
12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Serum levels of immunologic markers
時間枠：12 months
|
Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays |
12 months
|
協力者と研究者
協力者
捜査官
- 主任研究者：Riccardo Caccialanza, MD、Fondazione IRCCS Policlinico San Matteo
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 0020364/22
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Depending on a specific research question and according to a study protocol to be approved by the Ethics Committee
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。