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क्लिनिकल ट्रायल NCT03865992 के लिए स्तन कैंसर, जोड़ों का दर्द वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें।
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
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खोज पर वापस जाएँ

Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease

सक्रिय, भर्ती नहीं
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT03865992 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन है जो स्तन कैंसर, जोड़ों का दर्द से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 4 मार्च 2019 को हुई थी, और इसमें कुल 42 प्रतिभागियों के नामांकन की योजना है। सिटी ऑफ़ होप मेडिकल सेंटर इस परीक्षण का नेतृत्व कर रहे हैं और इसके 8 सितंबर 2026 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 7 नवंबर 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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).
विस्तृत विवरण
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.

आधिकारिक शीर्षक

Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study

चिकित्सीय स्थितियाँ
स्तन कैंसरजोड़ों का दर्द
प्रकाशन
इस नैदानिक परीक्षण के बारे में प्रकाशित वैज्ञानिक लेख और शोध पत्र:
अन्य अध्ययन आईडी
NCT नंबर
NCT03865992
अध्ययन प्रारंभ तिथि (वास्तविक)
2019-03-04
अंतिम अद्यतन प्रकाशित
2025-11-07
अध्ययन की समाप्ति तिथि (अनुमानित)
2026-09-08
नामांकन (अनुमानित)
42
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
Breast cancer
curcumin
aromatase inhibitor
joint pain
arthropathy
प्राथमिक उद्देश्य
सहायक देखभाल
डिज़ाइन आवंटन
यादृच्छिक
हस्तक्षेप मॉडल
समानांतर
अंधकरण
दोहरा अंध
समूह/हस्तक्षेप
प्रतिभागी समूह/हाथहस्तक्षेप/इलाज
प्रयोगात्मकArm 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.
Curcumin
Given capsules for oral administration
Nanoemulsion
Given nanoemulsion curcumin PO
जीवन की गुणवत्ता का मूल्यांकन
Ancillary studies
प्रश्नावली
Ancillary studies
प्लेसबो तुलना समूहArm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
प्लेसबो
Given capsules for oral administration
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
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
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
Incidence of adverse events
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
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
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
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
बच्चा, वयस्क, वृद्ध वयस्क
अध्ययन के लिए पात्र लिंग
महिला
  • 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")

  • 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
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कोई संपर्क डेटा नहीं।
4 1 देशों में अध्ययन स्थल

California

City of Hope Medical Center, Duarte, California, 91010, United States
City of Hope Rancho Cucamonga, Rancho Cucamonga, California, 91730, United States
City of Hope South Pasadena, South Pasadena, California, 91030, United States

Ohio

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States