EPA強化栄養による患者治療の最適化：無作為化比較試験 (OPT-EPA)
Malnutrition is a common and serious issue for people living with cancer. Many cancer patients experience weight loss, muscle weakness, and poor quality of life due to malnutrition. This can also reduce the success of cancer treatments, increase hospital visits, and add emotional distress for both patients and their loved ones.
Treating malnutrition through good nutritional care is increasingly recognised as an important part of cancer treatment. Leading experts recommend that all cancer patients be checked for signs of malnutrition and given personalised nutrition plans when necessary. While dietary counselling and oral nutritional supplements (ONS) are often used to help patients, there is still a need for better evidence to show how well these interventions work.
A key factor contributing to malnutrition in cancer patients is inflammation. Omega-3 fatty acids, (like those found in oily fish) are known for their anti-inflammatory properties. Some studies suggest that omega-3s may help cancer patients by reducing inflammation, keeping muscles strong, improving appetite, and enhancing overall well-being.
The OPT-EPA study will investigate whether a nutritional drink, called Fortimel Forticare Sensations (FFS), can improve nutritional status in patients with lung or colorectal cancer who are at risk of malnutrition. This drink is enriched with omega-3 fatty acids (Eicosapentanoic acid (EPA) and Docosahexaenoic acid (DHA)) and provides a high amount of protein and calories in a small volume, making it easier to consume, especially for patients with taste changes.
In this study, participants will be divided into two groups. The experimental group will receive dietary counselling and standard care along with FFS, the omega-3-enriched nutritional drink, while the other (control) group will receive dietary counselling and standard care, with supplements provided only if clinically necessary. Researchers will evaluate the impact on patients' nutritional status, body weight, muscle, inflammation levels, and quality of life.
Through the OPT-EPA study, researchers hope to gain clearer insights into whether omega-3-containing supplements can provide meaningful benefits for cancer patients. Ultimately, this could help improve the quality of care and outcomes for people facing cancer-related malnutrition.
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：Jessica Kelly
- 電話番号：+442380599247
- メール：opt-epa@soton.ac.uk
研究連絡先のバックアップ
- 名前：Conni McCarthy
- メール：c.mccarthy@ed.ac.uk
研究場所
-
-
-
Edinburgh、イギリス
- 募集
- Edinburgh Cancer Centre
-
コンタクト：
- Iain Phillips
- 電話番号：01315371052
- メール：iain.phillips@nhs.scot
-
Gateshead、イギリス
- 募集
- Gateshead NHS Trust
-
コンタクト：
- Kerry Waterfield
- 電話番号：01914455712
- メール：kerry.waterfield@nhs.net
-
Liverpool、イギリス
- 募集
- Clatterbridge Cancer Centre
-
コンタクト：
- Seamus Coyle
- メール：seamus.coyle@nhs.net
-
-
-
-
-
Oslo、ノルウェー
- まだ募集していません
- Oslo University Hospital
-
コンタクト：
- Olav Olav
- 電話番号：+4722930000
- メール：uxolaj@ous-hf.no
-
-
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:
- Participants with stage III-IV lung and/or colorectal cancer undergoing systemic anti-cancer treatment (SACT) or starting SACT within the next 4 weeks *with non-curative intent
- Participants aged 18 or older
- Participants at nutritional risk defined as a BMI <20 kg/m2 and/or over 5% weight loss in the previous 6 months**
- Participants with systemic inflammation within 28 days of screening (CRP >10 mg/dL)
- Participants with an ECOG-PS*** score of 0, 1 or 2
- Participants willing and able to give written informed consent
Exclusion Criteria:
- Participants with a recent history of tumour resection (within 12 months)
- Participants with severe renal or hepatic failure or an intolerance to any of the ingredients of the study product
- Participants who are using dietary counselling, ONS or any form of artificial feeding at the time of recruitment
- Unable to adhere to either arm of the trial and appropriate requirements
- Contraindication to ONS including a lactose intolerance
- Females who are pregnant or of childbearing potential and not using adequate contraception
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 |
|---|---|
|
実験的：食事カウンセリングとEPA強化FFS（実験用ONS）および標準ケア
|
An EPA-enriched experimental Oral Nutritional Supplement |
|
介入なし：食事カウンセリングと標準治療
|
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 |
時間枠 |
|---|---|
|
体重 - 軽い服装、靴なし
時間枠：ベースラインから56日目まで
|
ベースラインから56日目まで
|
協力者と研究者
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
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。