Effect of Preoperative Curcumin in Breast Cancer Patients

Not Applicable

• Conditions: Breast Cancer
• Interventions: Other: Placebo; Dietary Supplement: Curcumin

• Registration Number: NCT03847623
• Lead Sponsor: University of Malaya

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 Timeline

• Study Start: 2017-06-18
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Capsules, taken orally, bi-daily dosing
Curcumin	Curcumin	Capsules, taken orally, 8g per day (Bi-daily dosing)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
FOXP3	For 2 to 4 weeks	Immunohistochemistry analysis
CD68	For 2 to 4 weeks	Immunohistochemistry analysis

Trial Locations

Locations (1)

University of Malaya Medical Center; 🇲🇾 Kuala Lumpur, Malaysia