NF-1, 기능 식품 개입
신경섬유종증 1형(NF1)에 대한 고페놀 엑스트라 버진 올리브 오일과 커큐민을 사용한 기능 식품 중재 연구
The treatment plan is identical for all participants with the exception of the curcumin dose level that is assigned at study enrollment. Participants are instructed to take the curcumin and olive oil one after the other (order does not matter) twice a day on an empty stomach ideally 30 minutes before breakfast and dinner.
Curcumin and high phenolic extra virgin olive oil (HP-EVOO) may continue for up to 12 months in the absence of unacceptable side effects.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- Masonic Cancer Center, University of Minnesota
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
- Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF
- Aged 18 years or older at the time of written consent
- Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care
Exclusion Criteria:
- Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation
- Conditions requiring systemic immunosuppression
- Swallowing difficulties or strong gag reflex which may interfere with study compliance
- Any comorbidities that may affect study participation in the judgement of enrolling investigator
- Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator
- Treatment with high phenolic olive oil or curcumin within six months of study entry
- Known pregnancy or anticipated conception during the 1 year study period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Curcumin with high phenolic extra virgin olive oil (HP-EVOO)
Identical for all participants with the exception of the curcumin dose level, which is assigned at study enrollment. |
identical for all participants with the exception of the curcumin dose level Dose 1: 1000 mg Curcumin daily dose with 1 capsule and 25 ml HP-EVOO volume at morning and night Dose 2: 2000 mg Curcumin daily dose with 2 capsules and 25 ml HP-EVOO volume at morning and night Dose 3: 4000 mg Curcumin daily dose with 4 capsules and 25 ml HP-EVOO volume at morning and night
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The primary objective of this study is to establish the safety and preliminary activity of curcumin and oleocanthal-rich olive oil supplementation in adult NF-1 persons with cutaneous neurofibromas.
기간: End of treatment (12 months)
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The safety of this supplementation will be measured by the incidence of unacceptable/dose limiting toxicity (DLT) as defined any new Grade 2 or greater toxicity (based on CTCAE v 5). |
End of treatment (12 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Characterize the toxicities associated with the planned intervention
기간: 4 weeks after 1st dose of curcumin
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Incidence of unacceptable/dose limiting toxicity defined as any new ≥Grade 2 toxicity (based on CTCAE v 5) that cannot be attributed to the disease under treatment or other reason. |
4 weeks after 1st dose of curcumin
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To evaluate the effect of the intervention on BMI
기간: End of Treatment (12 months)
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The BMI will be measures across dose level group 95% confidence intervals. |
End of Treatment (12 months)
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To evaluate the effect of the intervention on lipid panel
기간: End of Treatment (12 months)
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The lipid panel will be measures across dose level group 95% confidence intervals. |
End of Treatment (12 months)
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To assess the effect of the intervention on quality of life
기간: End of treatment (12 months)
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Focused on skin related morbidity and pain will be evaluated using the average and range of SkinDex scale (0-100) |
End of treatment (12 months)
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To determine preliminary efficacy of the intervention
기간: End of treatment (12 months)
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Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported) |
End of treatment (12 months)
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To identify issues with compliance to the planned intervention
기간: End of treatment (12 months)
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Incidence of study deviations |
End of treatment (12 months)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Clay Hoerig, MD, Masonic Cancer Center, Univeristy of Minnesota
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2021LS032
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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