EPA 강화 영양으로 환자 치료 최적화, 무작위 대조군 임상시험 (OPT-EPA)
EPA 강화 영양을 통한 환자 치료 최적화, 무작위 대조 시험
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jessica Kelly
- 전화번호: +442380599247
- 이메일: opt-epa@soton.ac.uk
연구 연락처 백업
- 이름: Conni McCarthy
- 이메일: c.mccarthy@ed.ac.uk
연구 장소
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Oslo, 노르웨이
- 아직 모집하지 않음
- Oslo University Hospital
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연락하다:
- Olav Olav
- 전화번호: +4722930000
- 이메일: uxolaj@ous-hf.no
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Edinburgh, 영국
- 모병
- Edinburgh Cancer Centre
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연락하다:
- Iain Phillips
- 전화번호: 01315371052
- 이메일: iain.phillips@nhs.scot
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Gateshead, 영국
- 모병
- Gateshead NHS Trust
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연락하다:
- Kerry Waterfield
- 전화번호: 01914455712
- 이메일: kerry.waterfield@nhs.net
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Liverpool, 영국
- 모병
- Clatterbridge Cancer Centre
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연락하다:
- Seamus Coyle
- 이메일: seamus.coyle@nhs.net
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 식이 상담 및 EPA 강화 FFS(실험용 경구 영양 보충제) 및 표준 치료
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An EPA-enriched experimental Oral Nutritional Supplement |
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간섭 없음: 식이 상담 및 표준 치료
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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체중 - 가벼운 옷, 신발 없음
기간: 기준 시점부터 56일차까지
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기준 시점부터 56일차까지
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .