アロマターゼ阻害剤誘発性関節疾患の乳癌生存者の関節痛を軽減するクルクミン
アロマターゼ阻害剤誘発性関節症の乳がんサバイバーに対するクルクミン - 無作為化二重盲検対照パイロット研究
This phase I trial studies how well curcumin works in reducing joint pain in patients who are breast cancer survivors and have joint disease caused by treatment with aromatase inhibitors. Curcumin is an ingredient of turmeric, a plant in the ginger family, which is commonly used in curries and South Asian and Middle Eastern cooking, and may decrease joint pain in patients with arthritis from other conditions (such as osteoarthritis and rheumatoid arthritis).
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of using Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scores to detect changes in AI-induced symptoms and well-being in postmenopausal women with breast cancer at 3 months of nanoemulsion curcumin (NEC) vs placebo
SECONDARY OBJECTIVES:
I. To evaluate Disabilities of the Arm, Shoulder and Hand (DASH), Brief Pain Inventory, and Geriatric Assessment as secondary tools for monitoring AI-induced symptoms and well-being II. To evaluate adherence to a regimen of NEC vs placebo by postmenopausal women experiencing joint arthropathy induced by aromatase inhibitor therapy III. To obtain preliminary data regarding function in women with AI induced arthropathy (IA) by monitoring grip strength at 0 and 3 months of NEC versus placebo IV. To conduct exploratory analyses of blood based biomarkers in postmenopausal women with AI-induced arthropathy taking NEC vs placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
Duarte、California、アメリカ、91010
- City of Hope Medical Center
-
Rancho Cucamonga、California、アメリカ、91730
- City of Hope Rancho Cucamonga
-
South Pasadena、California、アメリカ、91030
- City of Hope South Pasadena
-
-
Ohio
-
Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Women with histologically confirmed primary invasive adenocarcinoma of the breast, stages I-IIIA
- Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) breast cancer
- Completion of definitive surgery with mastectomy or breast conserving therapy
- Postmenopausal (no menses >= 12 months) or on ovarian suppression in order to take AIs
- Currently taking an Food and Drug Administration (FDA) approved third-generation aromatase inhibitor (e.g., anastrozole [Arimidex], letrozole [Femara], or exemestane [Aromasin]) for >= 90 days prior to registration with plans to continue for >= 90 days after registration
- Clinical symptoms of joint pain for at least 3 months prior to study entry that started or increased with AI therapy with Brief Pain Inventory (BPI) Worst Pain score >= 4 (verbal response to BPI question 3 regarding the worst pain in the past 24 hours as 0 "no pain" to 10 "pain as bad as you can imagine")
Exclusion Criteria:
- Prior malignancy =< 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission
- History of a bleeding tendency or current use of coumadin or other anticoagulants
- Current or previous history of anemia
- Current autoimmune, liver, hematopoietic, cardiac, or renal disease
- Current viral, bacterial, atypical or fungal infections of any organ system
- Concurrent use of immunosuppressant medications
- Concurrent use of medications known to inhibit or induce hepatic enzyme CYP 3A4 (e.g. ketoconazole, macrolide antibiotics, barbiturates)
- 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 situation that would limit compliance with study requirements
- Bone fracture or surgery of the affected joints, within 180 days of study entry
- Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness =< 30 days of study entry
- Intra-articular steroids =< 90 days of study entry or oral/intramuscular corticosteroids < 30 days of entry
- Use of analgesics (e.g., opiates, tramadol with the exception of nonsteroidal anti-inflammatory drugs [NSAIDs] and acetaminophen) within 14 days prior to registration, or at any time during the 3-month study period
- Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids =< 3 months of study entry or any other supplements that might interact with NEC (e.g. St. John's Wort)
- Known sensitivity or allergy to turmeric spices or curry
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I (nanoemulsion curcumin)
Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity. |
Ancillary studies
他の名前：
Given capsules for oral administration
他の名前：
Given nanoemulsion curcumin PO Ancillary studies
他の名前：
|
|
プラセボコンパレーター：Arm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity. |
Given capsules for oral administration
他の名前：
|
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 |
|---|---|---|
|
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
時間枠：Up to 3 months
|
The study will assess the feasibility of using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) to detect changes in aromatase inhibitor (AI)-induced symptoms and well-being in postmenopausal women with breast cancer randomized to 3 months of nanoemulsion curcumin (NEC) versus (vs) placebo capsules. |
Up to 3 months
|
|
Change in Brief Pain Inventory (BPI) pain score
時間枠：Baseline up to 3 months
|
The scores obtained from the Disabilities of the Arm, Shoulder and Hand (DASH) and BPI, and FACT-ES assessments will be plotted over time for each arm. The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation. |
Baseline up to 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events
時間枠：Up to 30 days post study-drug assessment
|
Adverse events will be characterized using the descriptions and grading scales found in the most recent version of the Common Terminology Criteria for Adverse Events version 5.0. |
Up to 30 days post study-drug assessment
|
|
Change in FACT-ES score
時間枠：Baseline up to 3 months
|
The scores obtained from the BPI, DASH, and FACT-ES assessments will be plotted over time for each arm. The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation |
Baseline up to 3 months
|
|
Change in DASH score
時間枠：Baseline up to 3 months
|
The scores obtained from the BPI, DASH, and FACT-ES assessments will be plotted over time for each arm. The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation. |
Baseline up to 3 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Joint symptoms occurrence
時間枠：Up to 3 months
|
The study will use logistic regression models to compare the occurrence of moderate to severe joint symptoms during the 3 month period between the two study groups, with potential covariates including geriatric assessment (GA), age, body mass index, baseline pain scores (0 month), prior chemotherapy e.g. taxanes, time to menopause/ovarian suppression. Summary statistics will be generated using the data obtained from the T0 and T3 study visits where grip strength dynamometry completed. Temporal as well as other relevant correlations between the data and the validated assessment scores will be determined. |
Up to 3 months
|
|
Blood based biomarker analysis
時間枠：Up to 3 months
|
The study will explore the relationship between specific inflammatory blood markers, grip strength, and the joint symptoms evaluated by the patient reported outcome measures. The relationship between plasma curcumin and these measures will also be evaluated. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pair wise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots. |
Up to 3 months
|
|
Adherence rates
時間枠：Up to 3 months
|
Adherence rates will be examined using pill counts each month and patient recorded daily logs. Plasma curcumin will be compared to daily logs and pill count data as another potential measure of adherence. |
Up to 3 months
|
協力者と研究者
捜査官
- 主任研究者：Lisa D Yee, MD、City of Hope Medical Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
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
- 18432
- UG1CA189823 (米国 NIH グラント/契約)
- 18432 (その他の識別子：City of Hope Medical Center)
- NCI-2018-03787 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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
米国で製造され、米国から輸出された製品。
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。