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

Primary Purpose

Breast Cancer, Joint Pain

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Curcumin

Placebo

Nanoemulsion

Quality-of-Life Assessment

Questionnaire

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, curcumin, aromatase inhibitor, joint pain, arthropathy

Eligibility Criteria

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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+) 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")

Exclusion Criteria:

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

Sites / Locations

City of Hope Medical Center
City of Hope Rancho Cucamonga
City of Hope South Pasadena
Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I (nanoemulsion curcumin)

Arm II (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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

Change in DASH score

Full Information

NCT ID

NCT03865992

First Posted

January 9, 2019

Last Updated

September 7, 2023

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT03865992

Brief Title

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

Official Title

Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 4, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Joint Pain

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (nanoemulsion curcumin)

Arm Type

Experimental

Arm Description

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

Arm Title

Arm II (placebo)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Curcumin

Other Intervention Name(s)

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

Intervention Description

Given capsules for oral administration

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

placebo therapy, PLCB, sham therapy

Intervention Description

Given capsules for oral administration

Intervention Type

Other

Intervention Name(s)

Nanoemulsion

Intervention Description

Given nanoemulsion curcumin PO

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment,

Intervention Description

Ancillary studies

Intervention Type

Behavioral

Intervention Name(s)

Questionnaire

Other Intervention Name(s)

Questionnaires

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 3 months

Title

Change in Brief Pain Inventory (BPI) pain score

Description

Time Frame

Baseline up to 3 months

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Description

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.

Time Frame

Up to 30 days post study-drug assessment

Title

Change in FACT-ES score

Description

Time Frame

Baseline up to 3 months

Title

Change in DASH score

Description

Time Frame

Baseline up to 3 months

Other Pre-specified Outcome Measures:

Title

Joint symptoms occurrence

Description

The study will use logistic regression models to compare the occurrence of moderate to severe joint symptoms during the 3 month period between the two study groups, with potential covariates including geriatric assessment (GA), age, body mass index, baseline pain scores (0 month), prior chemotherapy e.g. taxanes, time to menopause/ovarian suppression. Summary statistics will be generated using the data obtained from the T0 and T3 study visits where grip strength dynamometry completed. Temporal as well as other relevant correlations between the data and the validated assessment scores will be determined.

Time Frame

Up to 3 months

Title

Blood based biomarker analysis

Description

The study will explore the relationship between specific inflammatory blood markers, grip strength, and the joint symptoms evaluated by the patient reported outcome measures. The relationship between plasma curcumin and these measures will also be evaluated. Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pair wise relation. The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.

Time Frame

Up to 3 months

Title

Adherence rates

Description

Adherence rates will be examined using pill counts each month and patient recorded daily logs. Plasma curcumin will be compared to daily logs and pill count data as another potential measure of adherence.

Time Frame

Up to 3 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

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+) 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") Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa D Yee, MD

Organizational Affiliation

City of Hope Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

City of Hope Rancho Cucamonga

City

Rancho Cucamonga

State/Province

California

ZIP/Postal Code

91730

Country

United States

Facility Name

City of Hope South Pasadena

City

South Pasadena

State/Province

California

ZIP/Postal Code

91030

Country

United States

Facility Name

Ohio State University Comprehensive Cancer Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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