PeRioperative Optimization With Nutritional Supplements for Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS)
PeRioperative Optimization With Nutritional Supplements in Patients Undergoing GastRointEStinal Surgery for Cancer (PROGRESS): A Randomized Placebo Controlled Feasibility Study.
This is a single-center randomized, placebo-controlled, double-blind feasibility study comparing the intervention of perioperative nutritional supplements (immunomodulation, carbohydrate loading, and protein isolate) with an identical placebo for each solution in patients with gastrointestinal cancer undergoing surgery. Eligible and consenting patients will be randomly allocated to receive the intervention or placebo in a 1:1 ratio.
This study will assess the feasibility of a large, multi-centre trial by establishing the feasibility of randomization to intervention or placebo. This study will be conducted at the Juravinski Hospital and will enroll 100 patients over 18 months.
The study intervention includes three perioperative nutritional supplements: (1) a protein supplement administered 3 times a day for 30 days before surgery, (2) a sugar-based supplement administered the day prior to and the day of surgery, and (3) a formulated liquid diet containing arginine, RNA, proteins and omega-6 fatty acids (referred to as immunonutrition for the purposes of this study) administered for 5 days prior to and 5 days after surgery.
The primary outcome for each eligible patient is defined as being randomized to intervention or placebo. The criteria for success of this study is defined as the proportion of eligible patients randomized as ≥ 60%. If the estimated proportion is <40%, the trial will be considered not feasible. If the proportion is between 40%-59%, the trial will be considered feasible with modifications to improve enrolment. Other secondary objectives include compliance with study intervention, estimating differences in postoperative complications, length of hospital stay, and quality of life between groups.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Hamilton、Ontario、カナダ、L8V1C3
- Hamilton Health Sciences
-
-
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:
- Men and women 18 years of age or older
- Diagnosed with a resectable type of gastrointestinal cancer (e.g. cancers of the gallbladder, liver, pancreas, stomach, small intestine, colon and rectum) for which an elective operation is planned (resection vs. palliative procedure).
- Patients with distant metastasis are eligible for the study.
- Patients who are lactose intolerant are also eligible for the study because the amount of lactose in ISOlution and PreCovery is minimal (trace).
Exclusion Criteria:
- Malabsorption syndrome (e.g. chronic pancreatitis)
- Cannot tolerate oral intake (e.g. gastric outlet obstruction or delayed gastric emptying)
- Organ failure (liver, kidney); end stage liver disease with a Child Pugh Score ≥ B or end stage renal disease defined as stages 3 and 4 with a glomerular filtration rate between 30-59 for stage 3 and 15-29 for stage 4.
- Inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematous, Crohn's disease and ulcerative colitis
- Patients currently on steroids
- Poorly controlled type 1 or 2 diabetes mellitus
- Female patients who are pregnant and/or lactating
- Galactosemia
- Ongoing infection.
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：防止
- 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 |
|---|---|
|
プラセボコンパレーター：Placebo
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
|
Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
|
|
実験的：Nutritional Supplements
carbohydrate loading, immunonutrition (formulated liquid diet), protein supplement
|
PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement.
他の名前：
|
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 |
|---|---|---|
|
The number of patients randomized to the study
時間枠：21 months
|
Feasibility of this study will be determined by the number of eligible patients randomized to intervention or placebo.
|
21 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The number of patients who comply with the study intervention regimen
時間枠：30 days before index surgery, and up to 5 days after index surgery
|
Compliance will be defined as intake of at least 70% of study intervention regimen.
|
30 days before index surgery, and up to 5 days after index surgery
|
|
Overall Complications
時間枠：3 months after index surgery
|
Occurrence of any postoperative complication (major or minor) from surgery following each patient's hospital stay and up to 90 days from the initial operation.
Occurrence of any postoperative infections will also be calculated.
|
3 months after index surgery
|
|
Comprehensive Complication Index
時間枠：3 months after index surgery
|
At 90 days from the index operation will be determined for each patient.
This index can be calculated for each patient using the online calculator www.assessurgery.com25
following the grading of each postoperative complication according to Clavien-Dindo.
|
3 months after index surgery
|
|
Quality of Life (QoL) - EORTC-QLQ-C Instrument
時間枠：Baseline, 1 month, and 3 months after index surgery
|
The global health related QoL at baseline, 1 and 3 months following randomization measured using the EORTC-QLQ-C instrument.
|
Baseline, 1 month, and 3 months after index surgery
|
|
Quality of Life (QoL) - FACT-G Scale
時間枠：Baseline, 1 month, and 3 months after index surgery
|
The global health related QoL at baseline, 1 and 3 months following randomization measured using the FACT-G scale.
|
Baseline, 1 month, and 3 months after index surgery
|
|
Length of Hospital Stay
時間枠：1 month after index surgery
|
Will be determined for each patient.
|
1 month after index surgery
|
協力者と研究者
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 (実際)
研究の完了 (実際)
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。
消化器がんの臨床試験
-
Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Placeboの臨床試験
-
Shanghai Hengrui Pharmaceutical Co., Ltd.完了
-
Consano Bio募集坐骨神経痛 | 坐骨神経根症 | 腰仙神経根症 | 腰仙神経根症候群 | 腰仙部神経根痛 | 坐骨神経痛オーストラリア
-
Palacky University完了