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Curcumin för att minska ledvärk hos överlevande bröstcancer med aromatashämmare-inducerad ledsjukdom

15 oktober 2026 uppdaterad av: City of Hope Medical Center

Curcumin för bröstcanceröverlevande med aromatashämmare-inducerad ledartropati - en randomiserad, dubbelblind, kontrollerad pilotstudie

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).

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

42

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Duarte, California, Förenta staterna, 91010
        • City of Hope Medical Center
      • Rancho Cucamonga, California, Förenta staterna, 91730
        • City of Hope Rancho Cucamonga
      • South Pasadena, California, Förenta staterna, 91030
        • City of Hope South Pasadena
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210
        • Ohio State University Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Quality-of-Life Assessment

Ancillary studies

Andra namn:
  • Livskvalitetsbedömning,
Kosttillskott: Curcumin

Given capsules for oral administration

Andra namn:
  • C.I. 75300
  • C.I. Naturgul 3
  • Diferuloylmetan
  • Gurkmeja gul
  • (E,E)-1,7-bis(4-hydroxi-3-metoxifenyl)-1,6-heptadien-3,5-dion, 32982, 458-37-7
Övrig: Nanoemulsion

Given nanoemulsion curcumin PO

Beteende: Questionnaire

Ancillary studies

Andra namn:
  • Frågeformulär
Placebo-jämförare: Arm II (placebo)

Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
Övrig: Placebo

Given capsules for oral administration

Andra namn:
  • placeboterapi
  • PLCB
  • skenterapi

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of adverse events
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Joint symptoms occurrence
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

City of Hope Medical Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Lisa D Yee, MD, City of Hope Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 april 2019

Primärt slutförande (Beräknad)

4 augusti 2027

Avslutad studie (Beräknad)

4 augusti 2027

Studieregistreringsdatum

Först inskickad

9 januari 2019

Först inskickad som uppfyllde QC-kriterierna

5 mars 2019

Första postat (Faktisk)

7 mars 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 18432
  • UG1CA189823 (U.S.S. NIH-anslag/kontrakt)
  • 18432 (Annan identifierare: City of Hope Medical Center)
  • NCI-2018-03787 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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