NCT03847623

Brief Summary

Effect of curcumin on modulation of immune and inflammatory parameters in pre-operative patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3.5 years

First QC Date

February 14, 2019

Last Update Submit

March 24, 2020

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumour infiltrating lymphocytes (TILs)

    Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group

    For 2 to 4 weeks

Secondary Outcomes (2)

  • FOXP3

    For 2 to 4 weeks

  • CD68

    For 2 to 4 weeks

Study Arms (2)

Curcumin

EXPERIMENTAL

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

Dietary Supplement: Curcumin

Placebo

PLACEBO COMPARATOR

Capsules, taken orally, bi-daily dosing

Other: Placebo

Interventions

CurcuminDIETARY_SUPPLEMENT

Natural compound, active ingredient of turmeric, in bi-daily dosing

Curcumin
PlaceboOTHER

Placebo tablets at bi-daily dosing

Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Nur Aishah Taib, MBBS

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 20, 2019

Study Start

June 18, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

MY(1)