Effect of Preoperative Curcumin in Breast Cancer Patients (EPC)

March 24, 2020 updated by: Nur Aishah Mohd Taib, University of Malaya
Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia
        • University of Malaya Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Curcumin
Capsules, taken orally, 8g per day (Bi-daily dosing)
Dietary supplement: Curcumin
Natural compound, active ingredient of turmeric, in bi-daily dosing
Placebo Comparator: Placebo
Capsules, taken orally, bi-daily dosing
Other: Placebo
Placebo tablets at bi-daily dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour infiltrating lymphocytes (TILs)
Time Frame: For 2 to 4 weeks
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group
For 2 to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FOXP3
Time Frame: For 2 to 4 weeks
Immunohistochemistry analysis
For 2 to 4 weeks
CD68
Time Frame: For 2 to 4 weeks
Immunohistochemistry analysis
For 2 to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 18, 2019

First Posted (Actual)

February 20, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20149-582

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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