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

NCT03865992 | Active Not Recruiting DMC

• 3 other identifiers: 18432NCI-2018-03787UG1CA189823
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Breast Cancer; Joint Pain

Keywords

Breast cancer; curcumin; aromatase inhibitor; joint pain; arthropathy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Incidence of adverse events

  Up to 30 days post study-drug assessment

• Change in FACT-ES score

  Baseline up to 3 months

• Change in DASH score

  Baseline up to 3 months

Other Outcomes (3)

• Joint symptoms occurrence

  Up to 3 months

• Blood based biomarker analysis

  Up to 3 months

• Adherence rates

  Up to 3 months

Study Arms (2)

Arm I (nanoemulsion curcumin)

EXPERIMENTAL

Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.

Dietary Supplement: Curcumin; Other: Nanoemulsion; Other: Quality-of-Life Assessment; Behavioral: Questionnaire

Arm II (placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Curcumin DIETARY_SUPPLEMENT

Given capsules for oral administration

Also known as: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow, (E,E)-1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione, 32982, 458-37-7

Arm I (nanoemulsion curcumin)

Placebo OTHER

Given capsules for oral administration

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Nanoemulsion OTHER

Given nanoemulsion curcumin PO

Arm I (nanoemulsion curcumin)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment,

Arm I (nanoemulsion curcumin)

Questionnaire BEHAVIORAL

Ancillary studies

Also known as: Questionnaires

Arm I (nanoemulsion curcumin)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Rancho Cucamonga

Rancho Cucamonga, California, 91730, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Lustberg M, Fan-Havard P, Wong FL, Hill K, Phelps MA, Herrera KW, Tsai NC, Synold T, Feng Y, Kalu C, Sedrak MS, Yee LD. Randomized placebo-controlled, double-blind clinical trial of nanoemulsion curcumin in women with aromatase inhibitor-induced arthropathy: an Alliance/NCORP pilot trial. Breast Cancer Res Treat. 2024 May;205(1):61-73. doi: 10.1007/s10549-023-07223-4. Epub 2024 Jan 27.

  PMID: 38280052 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia; Joint Diseases

Interventions

Curcumin; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Lisa D Yee, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: March 7, 2019
• Study Start: March 4, 2019
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (4)