Atypical Ductal Breast HyperplasiaNCT01975363
Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer
A study testing curcumin, Biomarker analysis and Assessment of Dietary Intake in people with Atypical Ductal Breast Hyperplasia and BRCA1 Gene Mutation, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Atypical Ductal Breast Hyperplasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation
- What is being tested?
- curcumin, Biomarker analysis and Assessment of Dietary Intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 19 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Increased risk for breast cancer based on family history, personal history
- Normal mammogram, clinical breast examination in the past 12 months
- >1 year from pregnancy, lactation or chemotherapy
- Body mass index (BMI) between 25 - 40
Who cannot join
- Concurrent malignancy or metastatic malignancy of any kind
- Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
- History of a bleeding tendency or current use of Coumadin or other anticoagulants
- Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
- Concurrent use of hormonal contraception or hormone replacement therapy
Show all 14Show fewer
- Concurrent use of immunosuppressant medications
- Concurrent use of medications known to inhibit or induce hepatic enzyme cytochrome P450 (CYP) 3A4
- Barriers to fine needle aspiration sampling of breast adipose, including breast implants, history of radiation to both breasts, bilateral mastectomies, and/or insufficient breast adipose tissue for adequate fine needle aspiration (FNA) sampling
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hypertension, or psychiatric illness/social situation that would limit compliance with study requirements
- Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids within the 3 months prior to entry on the study or any other supplements that might interact with NEC
- Known sensitivity or allergy to turmeric spices or curry
- Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
- Subjects on a standing regimen of full dose aspirin (>= 325 mg/day), non-steroidal anti-inflammatory drug (NSAID)s or NSAID-containing products
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial
This randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
i.) To determine whether nanoemulsion curcumnin modulates pro-inflammatory biomarkers in plasma and breast adipose tissue.
SECONDARY OBJECTIVES include:
ii.) To determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC) in women at high risk for developing breast cancer;
iii.) Evaluate possible correlations between physical factors such as body mass index (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
iv.) Explore additional biomarkers as surrogate endpoints to measure effects of NEC.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive lower dose of nanoemulsion curcumin orally (PO) twice daily (BID) for 3 months.
ARM II: Participants receive 100 mg of nanoemulsion curcumin PO BID for 3 months.
- Conditions
- Atypical Ductal Breast Hyperplasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
- Being tested
- curcumin, Biomarker analysis, Assessment of Dietary Intake, Daily Log
- Keywords
- Breast Cancer
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
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, CU, Diferuloylmethane
Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
Biomarker analysisOther
Also called Correlative studies, Breast adipose tissue, plasma samples
Breast adipose tissue and plasma samples will be obtained at baseline and 3 months for biomarker analyses. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin/COG and also stored at -80°C for biomarker analyses.
Assessment of Dietary IntakeOther
Also called questionnaires
Food frequency questionnaires will be obtained at 0 months and 24-hour dietary recalls will be obtained at 1, 2 and 3 months of the study.
Daily LogOther
All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (lower dose curcumin) | Experimental | Participants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications. Receives: Dietary Supplement: curcumin; Other: Biomarker analysis; Other: Assessment of Dietary Intake; Other: Daily Log |
| Arm II (higher dose curcumin) | Experimental | Participants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications. Receives: Dietary Supplement: curcumin; Other: Biomarker analysis; Other: Assessment of Dietary Intake; Other: Daily Log |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.
Measured: Up to 3 months
Secondary outcomes (1)
Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
Measured: 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 posted4 Nov 2013 (estimated)
- Study startJun 2013
- Primary completion19 Sep 2016
- Study completion19 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atypical Ductal Breast HyperplasiaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Clinton, Ohio State University Comprehensive Cancer Center
- Investigators
- Steven Clinton, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975363
- Sponsor's protocol ID
- OSU-13034
- Other IDs
- NCI-2013-01199
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2013
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanoemulsion Curcumin for Obesity, Inflammation and Breast Cancer Prevention - a Pilot Trial
- ClinicalTrials.gov ID
- NCT01975363
- Acronym / sponsor ID
- OSU-13034
- Conditions
- Atypical Ductal Breast Hyperplasia, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 19 Sep 2016 (actual)
- Study completion
- 19 Sep 2016 (actual)
- First posted
- 4 Nov 2013 (estimated)
- 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 randomized pilot clinical trial studies a nanoemulsion formulation of curcumin in reducing inflammatory changes in breast tissue in obese women at high risk for breast cancer. Curcumin may reduce inflammation in breast tissue and fat. This may affect the risk of developing breast cancer.
Detailed description
PRIMARY OBJECTIVES:
i.) To determine whether nanoemulsion curcumnin modulates pro-inflammatory biomarkers in plasma and breast adipose tissue.
SECONDARY OBJECTIVES include:
ii.) To determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC) in women at high risk for developing breast cancer;
iii.) Evaluate possible correlations between physical factors such as body mass index (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
iv.) Explore additional biomarkers as surrogate endpoints to measure effects of NEC.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive lower dose of nanoemulsion curcumin orally (PO) twice daily (BID) for 3 months.
ARM II: Participants receive 100 mg of nanoemulsion curcumin PO BID for 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (lower dose curcumin) | Experimental | Dietary Supplement: curcumin, Other: Biomarker analysis, Other: Assessment of Dietary Intake, Other: Daily LogParticipants receive 50 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Assessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications. |
| Arm II (higher dose curcumin) | Experimental | Dietary Supplement: curcumin, Other: Biomarker analysis, Other: Assessment of Dietary Intake, Other: Daily LogParticipants receive 100 mg dose curcumin PO BID for 3 months. Biomarker analyses of breast adipose tissue and plasma samples will be obtained at baseline and 3 months. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin and also stored at -80°C for biomarker analysis. Asssessment of dietary intake by food frequency questionnaires and 24 hour dietary recalls will be used to assess usual dietary habits. All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Increased risk for breast cancer based on family history, personal history
- Normal mammogram, clinical breast examination in the past 12 months
- >1 year from pregnancy, lactation or chemotherapy
- Body mass index (BMI) between 25 - 40
Key exclusion criteria (14 listed)
- Concurrent malignancy or metastatic malignancy of any kind
- Ongoing chemotherapy, radiation therapy, or other cancer-related treatment
- History of a bleeding tendency or current use of Coumadin or other anticoagulants
- Current or previous history of liver, gastrointestinal, hematopoietic, cardiac or renal disease, viral, bacterial, atypical or fungal infections of any organ system and human immunodeficiency virus (HIV) infection
- Pregnant or lactating women
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, CU, DiferuloylmethaneParticipants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period. | Dietary supplement | Arm I (lower dose curcumin), Arm II (higher dose curcumin) |
| Biomarker analysisAlso: Correlative studies, Breast adipose tissue, plasma samplesBreast adipose tissue and plasma samples will be obtained at baseline and 3 months for biomarker analyses. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin/COG and also stored at -80°C for biomarker analyses. | Other | Arm I (lower dose curcumin), Arm II (higher dose curcumin) |
| Assessment of Dietary IntakeAlso: questionnairesFood frequency questionnaires will be obtained at 0 months and 24-hour dietary recalls will be obtained at 1, 2 and 3 months of the study. | Other | Arm I (lower dose curcumin), Arm II (higher dose curcumin) |
| Daily LogAll participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications. | Other | Arm I (lower dose curcumin), Arm II (higher dose curcumin) |
Primary outcome
Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer.
Time frame: Up to 3 months
Confidence interval estimates will be obtained from the repeated analysis of variance and two-sample t tests.
1 secondary outcome
Evaluate possible correlations between physical factors such as body mass (BMI), dietary intake and pro-inflammatory effects in plasma and breast adipose tissue.
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Steven Clinton, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcumin, Biomarker analysis and Assessment of Dietary Intake in people with Atypical Ductal Breast Hyperplasia and BRCA1 Gene Mutation, run by Ohio State University Comprehensive Cancer Center at 1 site 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 4 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: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the adherence, tolerability and safety of two doses of nanoemulsion curcumin (NEC)in women at high risk for developing breast cancer. (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2019.