search
Back to results

Effect of Preoperative Curcumin in Breast Cancer Patients (EPC)

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Curcumin
Placebo
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Malaya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Curcumin

Placebo

Arm Description

Capsules, taken orally, 8g per day (Bi-daily dosing)

Capsules, taken orally, bi-daily dosing

Outcomes

Primary Outcome Measures

Tumour infiltrating lymphocytes (TILs)
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group

Secondary Outcome Measures

FOXP3
Immunohistochemistry analysis
CD68
Immunohistochemistry analysis

Full Information

First Posted
February 14, 2019
Last Updated
March 24, 2020
Sponsor
University of Malaya
search

1. Study Identification

Unique Protocol Identification Number
NCT03847623
Brief Title
Effect of Preoperative Curcumin in Breast Cancer Patients
Acronym
EPC
Official Title
Effect of Preoperative Curcumin in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Curcumin
Arm Type
Experimental
Arm Description
Capsules, taken orally, 8g per day (Bi-daily dosing)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules, taken orally, bi-daily dosing
Intervention Type
Dietary Supplement
Intervention Name(s)
Curcumin
Intervention Description
Natural compound, active ingredient of turmeric, in bi-daily dosing
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets at bi-daily dosing
Primary Outcome Measure Information:
Title
Tumour infiltrating lymphocytes (TILs)
Description
Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group
Time Frame
For 2 to 4 weeks
Secondary Outcome Measure Information:
Title
FOXP3
Description
Immunohistochemistry analysis
Time Frame
For 2 to 4 weeks
Title
CD68
Description
Immunohistochemistry analysis
Time Frame
For 2 to 4 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nur Aishah Taib, MBBS
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
Country
Malaysia

12. IPD Sharing Statement

Learn more about this trial

Effect of Preoperative Curcumin in Breast Cancer Patients

We'll reach out to this number within 24 hrs