Limonene Study in Women With Breast Cancer
キーワード
概要
日付
| 最終確認済み: | 09/30/2017 |
| 最初に提出された: | 01/07/2010 |
| 提出された推定登録数: | 01/07/2010 |
| 最初の投稿: | 01/11/2010 |
| 最終更新が送信されました: | 10/24/2017 |
| 最終更新日: | 10/26/2017 |
| 実際の研究開始日: | 07/31/2009 |
| 一次完了予定日: | 02/28/2011 |
| 研究完了予定日: | 02/28/2011 |
状態または病気
介入/治療
Dietary Supplement: limonene
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: limonene | Dietary Supplement: limonene oral dosing at 2 gram QD |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | Female |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Women who are 18 years of age or older - Women electing to undergo excision surgery for early stage breast cancer - A minimum of 2 weeks from enrollment to definitive surgery - Underwent core needle biopsy for breast cancer diagnosis - No clinical evidence of metastatic breast cancer - ECOG performance status 0-1 - Participants must have normal organ and marrow function - Women of child-bearing potential must agree to use adequate contraception - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - Concurrent chemotherapy or radiation therapy - Use of selective estrogen receptor modifiers or aromatase inhibitors within the past 3 months or concurrently - History of other malignancies within the past 5 years excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment - Participated in another clinical intervention trial within the past 3 months - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Pregnant or breast-feeding women - Use of dietary supplement that contains large amounts of d-limonene (such as Heartburn Free with ROH10 and CoQ with d-limonene) within the past 3 months |
結果
主な結果の測定
1. breast tissue limonene level [2 - 6 weeks]
二次的な結果の測定
1. drug effect biomarkers in the breast tissue and serum [2 - 6 weeks]
