Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03980509
Recruitment Status : Not yet recruiting
First Posted : June 10, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Curcumin Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Curcumin
Curcumin 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.
Drug: Curcumin
Curcumin is an extract from turmeric




Primary Outcome Measures :
  1. Change in tumor proliferation rate [ Time Frame: Up to 56 days ]
    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 :
  1. Number of adverse events reported [ Time Frame: up to 84 days ]
    Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980509


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Alex Green    843-792-7573    hcc-clinical-trials@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Layout table for investigator information
Principal Investigator: Nancy DeMore, MD, FACS Medical University of South Carolina

Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03980509     History of Changes
Other Study ID Numbers: 103089
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Curcumin
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action