Breast CancerNCT03865992
Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
A study testing Curcumin, Nanoemulsion and Quality-of-Life Assessment in people with Breast Cancer and Joint Pain, run by City of Hope Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Joint Pain
- What is being tested?
- Curcumin, Nanoemulsion and Quality-of-Life Assessment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Apr 2019to 4 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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")
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
City of Hope Medical Center
Duarte, California, 91010
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, 91730
City of Hope South Pasadena
South Pasadena, California, 91030
About this study
Official title: Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study
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).
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Breast Cancer, Joint Pain
- Being tested
- Curcumin, Placebo, Nanoemulsion, Quality-of-Life Assessment, Questionnaire
- Keywords
- Breast cancer, curcumin, aromatase inhibitor, joint pain, arthropathy
- Medical subject headings
- Breast Neoplasms, Arthralgia, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric Yellow
Given capsules for oral administration
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given capsules for oral administration
NanoemulsionOther
Given nanoemulsion curcumin PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment,
Ancillary studies
QuestionnaireBehavioural
Also called Questionnaires
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline up to 3 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Baseline up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start30 Apr 2019
- Primary completion4 Aug 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa D Yee, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865992
- Sponsor's protocol ID
- 18432
- Other IDs
- NCI-2018-03787, 18432, UG1CA189823
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2019
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38280052
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03865992
- Acronym / sponsor ID
- 18432
- Conditions
- Breast Cancer, Joint Pain
- Keywords
- Breast cancer, curcumin, aromatase inhibitor, joint pain, arthropathy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 4 Aug 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (nanoemulsion curcumin) | Experimental | Dietary Supplement: Curcumin, Other: Nanoemulsion, Other: Quality-of-Life Assessment, Behavioral: QuestionnairePatients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity. |
| Arm II (placebo) | Placebo comparator | Other: PlaceboPatients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminAlso: C.I. 75300, C.I. Natural Yellow 3, Diferuloylmethane, Turmeric YellowGiven capsules for oral administration | Dietary supplement | Arm I (nanoemulsion curcumin) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven capsules for oral administration | Other | Arm II (placebo) |
| NanoemulsionGiven nanoemulsion curcumin PO | Other | Arm I (nanoemulsion curcumin) |
| Quality-of-Life AssessmentAlso: Quality of Life Assessment,Ancillary studies | Other | Arm I (nanoemulsion curcumin) |
| QuestionnaireAlso: QuestionnairesAncillary studies | Behavioural | Arm I (nanoemulsion curcumin) |
Primary outcome
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
Time frame: 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.
Change in Brief Pain Inventory (BPI) pain score
Time frame: 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.
3 secondary outcomes
Incidence of adverse events
Time frame: Up to 30 days post study-drug assessment
Change in FACT-ES score
Time frame: Baseline up to 3 months
Change in DASH score
Time frame: Baseline up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 38280052Lustberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa D Yee, MD principal investigator
City of Hope Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin, Nanoemulsion and Quality-of-Life Assessment in people with Breast Cancer and Joint Pain, run by City of Hope Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03865992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.