What is the mechanism of action of this treatment?

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapies, such as tamoxifen and aromatase inhibitors, work by blocking hormones like estrogen that can promote cancer growth. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapies, such as trastuzumab, focus on specific molecular targets like HER2 receptors on cancer cells, inhibiting their growth and survival. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Anti-inflammatory agents like curcumin, studied for their potential to reduce joint pain in breast cancer survivors, may also help by reducing inflammation, which can be a contributing factor in cancer progression. Understanding these mechanisms is crucial for breast cancer patients as it helps tailor treatments to their specific cancer type and improve outcomes by targeting the underlying biological processes.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, hormone therapy, and targeted therapy, often come with a range of side effects. Chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infections. Hormone therapies, like aromatase inhibitors, may lead to joint pain, hot flashes, and bone thinning. Targeted therapies can result in skin rashes, diarrhea, and liver problems. Treatments with anti-inflammatory properties, such as curcumin, are being studied for their potential to reduce joint pain without severe side effects, but more research is needed to confirm their efficacy and safety.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, particularly for hormone receptor-positive types. Aromatase inhibitors such as letrozole and anastrozole are commonly used, although they have limited activity in certain cancers like endometrial cancer. These inhibitors work by reducing estrogen levels, which can help slow the growth of hormone-sensitive tumors. While curcumin is being studied for its anti-inflammatory properties in reducing joint pain caused by aromatase inhibitors, it is not yet an FDA-approved treatment for breast cancer itself.

What other types of research exist?

Promising novel alternatives to curcumin for breast cancer patients considering treatment in 2024 include: <ol> <li>Green Tea Polyphenols: These have shown potential in reversing cancer multidrug resistance and inhibiting cancer cell signaling pathways.</li> <li>Aspirin and Other NSAIDs: These have been studied for their role in reducing cancer metastasis and mortality, particularly in colorectal cancer, and may have potential applications in breast cancer.</li> <li>Selective COX-2 Inhibitors: While associated with cardiovascular risks, they have shown efficacy in cancer prevention and may be considered under careful medical supervision.</li> <li>Phytoestrogens (Genistein): Found in soybeans, these have shown some efficacy in reducing hot flashes and may have anti-cancer properties.</li> <li>Vitamin D: Studies suggest that adequate vitamin D levels may influence survival outcomes in cancer patients.</li> </ol>

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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

Must not have

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

Current autoimmune, liver, hematopoietic, cardiac, or renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Summary

This trial studies whether a special form of curcumin can reduce joint pain in breast cancer survivors who have pain from their cancer treatment. Curcumin, found in turmeric, is known for its anti-inflammatory effects. The trial aims to see if this natural substance can help these patients feel better. Curcumin, derived from turmeric, has been used in traditional medicine for centuries and has shown potential anticancer and anti-inflammatory properties in various studies.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not used strong painkillers, except for NSAIDs or acetaminophen, in the last 14 days and won't during the study.

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I have a current condition affecting my immune system, liver, blood, heart, or kidneys.

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I have or had anemia.

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I do not have any current infections.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have a history of bleeding easily or am currently using blood thinners.

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I am not taking medications that affect liver enzymes like CYP 3A4.

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I am currently taking medication that suppresses my immune system.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in DASH score

Change in FACT-ES score

Incidence of adverse events

Other study objectives

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

~1070

Questionnaire

2014

Completed Phase 2

~19970

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapies, such as tamoxifen and aromatase inhibitors, work by blocking hormones like estrogen that can promote cancer growth. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells. Targeted therapies, such as trastuzumab, focus on specific molecular targets like HER2 receptors on cancer cells, inhibiting their growth and survival. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Anti-inflammatory agents like curcumin, studied for their potential to reduce joint pain in breast cancer survivors, may also help by reducing inflammation, which can be a contributing factor in cancer progression. Understanding these mechanisms is crucial for breast cancer patients as it helps tailor treatments to their specific cancer type and improve outcomes by targeting the underlying biological processes.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

596 Previous Clinical Trials

1,923,495 Total Patients Enrolled

42 Trials studying Breast Cancer

6,607 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,958 Total Patients Enrolled

944 Trials studying Breast Cancer

1,543,922 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

~2 spots leftby Dec 2024

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