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Dietary Supplement

Curcumin for Joint Pain in Breast Cancer Survivors

N/A

Waitlist Available

Led By Lisa D Yee, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Completion of definitive surgery with mastectomy or breast conserving therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial will study how well curcumin works in reducing joint pain in breast cancer survivors with joint disease caused by treatment with aromatase inhibitors.

Who is the study for?

This trial is for postmenopausal breast cancer survivors with joint pain due to aromatase inhibitors. Participants must have had surgery for estrogen/progesterone-positive breast cancer and been on FDA-approved aromatase inhibitors for at least 90 days, planning to continue them. They should have a history of joint pain starting or worsening with the therapy.Check my eligibility

What is being tested?

The study tests if curcumin can reduce joint pain in these individuals compared to a placebo. Curcumin is derived from turmeric and may help arthritis-related discomfort. The trial includes taking curcumin or placebo, quality-of-life assessments, and questionnaires about the effect on joint pain.See study design

What are the potential side effects?

Potential side effects of curcumin may include digestive issues like upset stomach or nausea, allergic reactions for those sensitive to turmeric spices, and possibly interactions with certain medications that affect liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on an FDA-approved aromatase inhibitor for at least 90 days and plan to continue.

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I have completed surgery for breast cancer, either mastectomy or lumpectomy.

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I am postmenopausal or on treatment to suppress my ovaries for taking AIs.

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I have been diagnosed with early-stage breast cancer.

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I have had joint pain for 3 months or more, which started or got worse with AI therapy, and my worst pain score is 4 or higher.

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My breast cancer is positive for estrogen and/or progesterone receptors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Brief Pain Inventory (BPI) pain score

Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy

Secondary outcome measures

Change in DASH score

Change in FACT-ES score

Incidence of adverse events

Other outcome measures

Adherence rates

Blood based biomarker analysis

Joint symptoms occurrence

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (nanoemulsion curcumin)Experimental Treatment4 Interventions

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

Group II: Arm II (placebo)Placebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Curcumin

2017

Completed Phase 4

~1050

Questionnaire

2014

Completed Phase 2

~20090

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,418 Total Patients Enrolled

42 Trials studying Breast Cancer

6,607 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,111 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,318 Patients Enrolled for Breast Cancer

Lisa D Yee, MDPrincipal InvestigatorCity of Hope Medical Center

2 Previous Clinical Trials

105 Total Patients Enrolled

2 Trials studying Breast Cancer

105 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to volunteer for this clinical experiment?

"Clinicaltrials.gov affirms that recruitment for this clinical trial, which began on March 4th 2019 and ended on September 14th 2022, has concluded. Nonetheless, there are many other medical trials currently recruiting patients: 2631 to be exact."

Answered by AI

How many health facilities are participating in this clinical trial?

"Currently, this medical trial is taking place at 4 sites located in Columbus, South Pasadena, Rancho Cucamonga and other cities. If you wish to take part of the study it would be best to choose a nearby location as to not add unnecessary stress through extensive travel."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03865992.

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