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临床试验/NCT07255066
NCT07255066招募中不适用

Optimizing Patient Treatment With EPA-enriched Nutrition, a Randomised Control Trial

University of Edinburgh4 个研究点 分布在 2 个国家目标入组 118 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
118
试验地点
4
主要终点
Body Weight - light clothes, no shoes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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 weight loss between 5-10% in the previous 6 months**
  • •Participants with systemic inflammation within 28 days of screening (e.g. CRP >10 mg/dL)
  • •Participants with an ECOG-PS*** score of 0, 1 or 2
  • •Participants willing and able to give written informed consent

排除标准

  • •Participants with a recent history of tumour resection (within 12 months)
  • •Participants who have lost >10% body weight in the previous 6 months before baseline - observed or participant reported.
  • •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

研究组 & 干预措施

Dietary Counselling and EPA-enriched FFS (experimental ONS) and standard care

Experimental

干预措施: Fortimel Forticare Sensations (Dietary Supplement)

Dietary Counselling and standard care

No Intervention

结局指标

主要结局

Body Weight - light clothes, no shoes

时间窗: From baseline to day 56

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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