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Effect of Preoperative Curcumin in Breast Cancer Patients (EPC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847623
Recruitment Status : Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Nur Aishah Mohd Taib, University of Malaya

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE February 20, 2019
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE June 18, 2017
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
Tumour infiltrating lymphocytes (TILs) [ Time Frame: For 2 to 4 weeks ]
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • FOXP3 [ Time Frame: For 2 to 4 weeks ]
    Immunohistochemistry analysis
  • CD68 [ Time Frame: For 2 to 4 weeks ]
    Immunohistochemistry analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Preoperative Curcumin in Breast Cancer Patients
Official Title  ICMJE Effect of Preoperative Curcumin in Breast Cancer Patients
Brief Summary Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients
Detailed Description Patients diagnosed with breast cancer will be supplemented with either curcumin or placebo for a minimum period of 2 weeks and may be extended up to 4 weeks prior to their surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Dietary Supplement: Curcumin
    Natural compound, active ingredient of turmeric, in bi-daily dosing
  • Other: Placebo
    Placebo tablets at bi-daily dosing
Study Arms  ICMJE
  • Experimental: Curcumin
    Capsules, taken orally, 8g per day (Bi-daily dosing)
    Intervention: Dietary Supplement: Curcumin
  • Placebo Comparator: Placebo
    Capsules, taken orally, bi-daily dosing
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with operable breast cancer
  • Life expectancy of at least 3 months
  • Adequate organ function
  • No allergy to curcumin
  • Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria:

  • Receiving concomitant radiotherapy, hormonal, immune therapy or other investigational drugs
  • Uncontrolled concurrent illness
  • Patient of anti platelet medications
  • Pregnant / breast feeding
  • Patients who are unable or unwilling to take curcumin, herbal remedies, or non-prescription medications
  • Patients with bleeding tendency, bleeding disorders and abnormal bleeding/clotting profile
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03847623
Other Study ID Numbers  ICMJE 20149-582
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nur Aishah Mohd Taib, University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nur Aishah Taib, MBBS University of Malaya
PRS Account University of Malaya
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP