プラチナベースの化学療法を受けている婦人科がん患者におけるタンパク質、ロイシン、ビタミンDの補給 (PRODIGY-1)
第一選択のプラチナベースの化学療法を受けている婦人科がん患者におけるタンパク質、ロイシン、ビタミンDの補給
Open clinical trial addressing the effect of a nutritional support based on whey proteins, leucine and vitamin D on muscle mass and multiple anticancer treatment-related endpoints in patients with gynecologic cancer receiving first-line platinum-based chemotherapy (adjuvant or curative). A comparison to matched historical controls will be performed to address potential evidence of efficacy to be investigated in a subsequent randomized trial.
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：+390382501615
- メール：r.caccialanza@smatteo.pv.it
研究連絡先のバックアップ
- 名前：Emanuele Cereda, MD, PhD
- 電話番号：+390382501615
- メール：e.cereda@smatteo.pv.it
研究場所
-
-
Italy
-
Pavia、Italy、イタリア、27100
- 募集
- IRCCS San Matteo
-
主任研究者：
- Emanuele Cereda, MD, PhD
-
コンタクト：
- Emanuele Cereda, MD, PhD
- 電話番号：+390382501615
- メール：e.cereda@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:
- histologically confirmed diagnosis of gynecologic cancer (ovarian, uterine, cervical);
- indication for a first-line chemotherapy (adjuvant or curative) with a platinum-based regimen to be used by investigator's choice within the framework of good clinical practice and in agreement with current Italian Association of Medical Oncology guidelines;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
- signed informed consent.
Exclusion Criteria:
- age <18 years
- ECOG performance status >2
- indication to or ongoing artificial nutrition support
- known kidney failure (previous glomerular filtration rate <30 ml/min);
- known liver failure (Child B or C)
- endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- decompensated diabetes
- indications related to the study product: more than 10 µg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources; adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
- known allergy to milk, milk products or other components of the proposed interventions
- inclusion in other nutritional intervention trials
- patients refusal
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：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Muscle-targeted nutritional support
Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
Two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
他の名前：
|
|
他の：Standard of care
Control group receiving no nutritional intervention or on-demand non muscle-targeted nutritional intervention such as nutritional counseling with or without oral nutritional supplement |
Control group receiving no nutritional intervention or on-demand non muscle-targeted intervention such as nutritional counseling with or without oral nutritional supplement |
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 |
|---|---|---|
|
Change in muscle mass area
時間枠：18 weeks
|
Change in muscle mass at the end of first-line platinum-based chemotherapy (adjuvant or curative) evaluated with computed tomography scan at the level of the third lumbar vertebra |
18 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Skeletal muscle mass
時間枠：18 weeks
|
Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis |
18 weeks
|
|
Body weight
時間枠：18 weeks
|
Change in body weight during the study (assessed at each chemotherapy cycle) |
18 weeks
|
|
Protein-calorie intake
時間枠：18 weeks
|
Change in protein-calorie intake during the study (assessed at each chemotherapy cycle) |
18 weeks
|
|
Handgrip strength
時間枠：18 weeks
|
Change in handgrip strength |
18 weeks
|
|
Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0]
時間枠：18 weeks
|
Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0. Toxicity is graded on 0-5 ordinal scale where a higher score means a worse outcome. |
18 weeks
|
|
Adherence to treatment schedule
時間枠：18 weeks
|
Difference in the proportion of patients completing the treatment schedule as planned |
18 weeks
|
|
Total dose of chemotherapy administered
時間枠：18 weeks
|
To be calculated as the percentage of chemotherapy dose administered with respect to the treatment plan |
18 weeks
|
|
Patients requiring unplanned hospitalization
時間枠：18 weeks
|
The rate of patients requiring unplanned hospitalization (one or more) during the study will be calculated |
18 weeks
|
|
Tolerance to nutritional support
時間枠：18 weeks
|
Occurrence of events of gastrointestinal intolerance |
18 weeks
|
協力者と研究者
捜査官
- 主任研究者：Emanuele Cereda, MD, PhD、Fondazione IRCCS Policlinico San Matteo
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
- 0014137/23
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?
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
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