Effect of Preoperative Curcumin in Breast Cancer Patients | NCT03847623

Studies
Effect of Preoperative Curcumin in Breast Cancer Patients

NCT03847623

Sponsor

University of Malaya

Status

Unknown status

Last Update Posted

Mar 25, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

Curcumin
Placebo

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2017Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Feb 14, 2019

First Submission Date that Met QC Criteria

Feb 18, 2019

First Posted Date

Feb 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2020

Last Update Posted Date

Mar 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Curcumin	Dietary Supplement	Natural compound, active ingredient of turmeric, in bi-daily dosing	Curcumin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nur Aishah Taib, MBBS	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Malaya Medical Center		Kuala Lumpur			Malaysia

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003474	Curcumin

Ancestor Terms

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided