NF-1、栄養補助食品の介入
神経線維腫症1型（NF1）に対する高フェノールエキストラバージンオリーブオイルとクルクミンによる栄養補助食品の研究
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.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Minnesota
-
Minneapolis、Minnesota、アメリカ、55455
- Masonic Cancer Center, University of Minnesota
-
-
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:
- 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
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：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
他の名前：
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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 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.
時間枠：End of treatment (12 months)
|
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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Characterize the toxicities associated with the planned intervention
時間枠：4 weeks after 1st dose of curcumin
|
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
|
|
To evaluate the effect of the intervention on BMI
時間枠：End of Treatment (12 months)
|
The BMI will be measures across dose level group 95% confidence intervals. |
End of Treatment (12 months)
|
|
To evaluate the effect of the intervention on lipid panel
時間枠：End of Treatment (12 months)
|
The lipid panel will be measures across dose level group 95% confidence intervals. |
End of Treatment (12 months)
|
|
To assess the effect of the intervention on quality of life
時間枠：End of treatment (12 months)
|
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)
|
|
To determine preliminary efficacy of the intervention
時間枠：End of treatment (12 months)
|
Measure the volumetric measurement of target plexiform neurofibroma (% difference from baseline will be reported) |
End of treatment (12 months)
|
|
To identify issues with compliance to the planned intervention
時間枠：End of treatment (12 months)
|
Incidence of study deviations |
End of treatment (12 months)
|
協力者と研究者
捜査官
- 主任研究者：Clay Hoerig, MD、Masonic Cancer Center, Univeristy of Minnesota
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 (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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2021LS032
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。