Effect of Preoperative Curcumin in Breast Cancer Patients

Breast Cancer Clinical Trial

— EPC  

Official title:

Effect of Preoperative Curcumin in Breast Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03847623
• Other study ID #: 20149-582
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Dietary Supplement:
• Curcumin
Natural compound, active ingredient of turmeric, in bi-daily dosing

Other:
• Placebo
Placebo tablets at bi-daily dosing

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour infiltrating lymphocytes (TILs)	Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group	For 2 to 4 weeks
Secondary	FOXP3	Immunohistochemistry analysis	For 2 to 4 weeks
Secondary	CD68	Immunohistochemistry analysis	For 2 to 4 weeks