Clinical Trials /

A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors

NCT03980509

Description:

The purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.

Related Conditions:
  • Invasive Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors
  • Official Title: A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors

Clinical Trial IDs

  • ORG STUDY ID: 103089
  • NCT ID: NCT03980509

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
CurcuminCurcumin

Purpose

The purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.

Detailed Description

      The purpose of this study is to determine whether oral administration of Curcuma longa
      extract causes biological changes related to apoptosis (DNA fragmentation) and cell
      proliferation (Ki67) in primary tumors of breast cancer patients.
    

Trial Arms

NameTypeDescriptionInterventions
CurcuminExperimentalCurcumin will be given at 500mg by mouth twice a day, immediately after each meal. Curcumin will be given from the time surgical resection is scheduled until the night before surgical resection.
  • Curcumin

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed invasive breast cancer (stages I, II, or III) with primary
             tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam

          2. 18 years of age or older

          3. Subject must understand risks and benefits of the protocol and be able to give
             informed consent

          4. Women of childbearing potential (WOCBP) must agree to use an approved form of birth
             control and to have a negative pregnancy test result within 14 days of registration.
             WOCBP is defined as any female who has experienced menarche and who has not undergone
             surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not
             postmenopausal. Menopause is defined clinically as 12 consecutive months of amenorrhea
             in a woman over 45 in the absence of other biological or physiological causes

             Approved forms of birth control:

               -  combined (estrogen and progestogen containing) hormonal contraception associated
                  with inhibition of ovulation (oral, intra-vaginal, or transdermal)

               -  progestogen only hormonal contraception associated with inhibition of ovulation
                  (oral, injectable, or implantable)

               -  intrauterine device, intrauterine hormone-releasing system

               -  bilateral tubal occlusion/ligation

               -  vasectomized partner

               -  barrier contraception

               -  sexual abstinence

          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          6. Adequate hematologic and end organ function

          7. Ability and capacity to comply with the study and follow-up procedures

          8. Subjects must be scheduled for surgery at MUSC no less than 5 days from the planned
             start of day 1 and no more than 56 days from the planned start of day 1

          9. At least 6 sections of unstained slides should be obtained. If sufficient slides or
             tissue is unavailable, the patient will be excluded from the trial

        Exclusion Criteria:

          1. Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy

          2. Subjects with end-stage kidney disease and/or grade II liver dysfunction

          3. Subjects who are pregnant or are lactating.

          4. Subjects with bile duct obstruction, gallstones, predisposition to kidney stones(39),
             or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders(40)

          5. Subjects taking anti-coagulants or platelet inhibitors

          6. Subjects taking drugs metabolized by CYP3A4, CYP1A2, and CYP2A6 enzymes

          7. Subjects taking drugs that interact with P-glycoprotein (P-gp)

          8. Subjects taking any of the medications listed under Other Herb-Drug interactions
             according to the Memorial Sloan Kettering Cancer Center in section 5.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Change in tumor proliferation rate
Time Frame:Up to 56 days
Safety Issue:
Description:Change in tumor proliferation rate will be based on apoptosis (DNA fragmentation) and cell proliferation (Ki67) assays in biopsies pre and post treatment with curcumin

Secondary Outcome Measures

Measure:Number of adverse events reported
Time Frame:up to 84 days
Safety Issue:
Description:Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Medical University of South Carolina

Last Updated

February 23, 2021