Breast Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCurcumin
Natural compound, active ingredient of turmeric, in bi-daily dosing
OTHERPlacebo
Placebo tablets at bi-daily dosing
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumour infiltrating lymphocytes (TILs) | For 2 to 4 weeks | Scoring as per recommendations by International Immuno-Oncology Biomarker Working Group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CD68 | For 2 to 4 weeks | Immunohistochemistry analysis |
| FOXP3 | For 2 to 4 weeks | Immunohistochemistry analysis |
Countries
Malaysia
Outcome results
None listed