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

Last updated: November 6, 2025
Sponsor: City of Hope Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain (Pediatric)

Joint Injuries

Breast Cancer

Treatment

Questionnaire

Quality-of-Life Assessment

Curcumin

Clinical Study ID

NCT03865992
18432
18432
NCI-2018-03787
UG1CA189823
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

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+) breastcancer

  • Completion of definitive surgery with mastectomy or breast conserving therapy

  • Postmenopausal (no menses >= 12 months) or on ovarian suppression in order to takeAIs

  • Currently taking an Food and Drug Administration (FDA) approved third-generationaromatase inhibitor (e.g., anastrozole [Arimidex], letrozole [Femara], or exemestane [Aromasin]) for >= 90 days prior to registration with plans to continue for >= 90days after registration

  • Clinical symptoms of joint pain for at least 3 months prior to study entry thatstarted or increased with AI therapy with Brief Pain Inventory (BPI) Worst Painscore >= 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

Exclusion Criteria:

  • Prior malignancy =< 5 years except adequately treated basal cell or squamous cellskin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast oradequately treated stage I or II cancer from which the patient is currently incomplete 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 activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situation that would limit compliance withstudy 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/intramuscularcorticosteroids < 30 days of entry

  • Use of analgesics (e.g., opiates, tramadol with the exception of nonsteroidalanti-inflammatory drugs [NSAIDs] and acetaminophen) within 14 days prior toregistration, 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

Study Design

Total Participants: 42
Treatment Group(s): 5
Primary Treatment: Questionnaire
Phase:
Study Start date:
March 04, 2019
Estimated Completion Date:
September 08, 2026

Study Description

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.

Connect with a study center

  • City of Hope Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope Rancho Cucamonga

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • City of Hope South Pasadena

    South Pasadena, California 91030
    United States

    Site Not Available

  • City of Hope Medical Center

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • City of Hope Rancho Cucamonga

    Rancho Cucamonga 5385955, California 5332921 91730
    United States

    Site Not Available

  • City of Hope South Pasadena

    South Pasadena 5397717, California 5332921 91030
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ohio State University Comprehensive Cancer Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Site Not Available

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