Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.
Status:
Completed
Trial end date:
2017-07-06
Target enrollment:
Participant gender:
Summary
Tocotrienols have shown strong in vitro and in vivo anti-oxidant and anticancer activity,
promoting apoptosis and regulating oncogenic targets in breast cancer. However their clinical
use is still experimental especially in preoperative setting, where there are still no data
of antioxidant and antiinflammatory beneficial roles. This study is a prospective
observational clinical study enrolling 50 patients with primary breast cancer (T1-2, N0-1,
M0) who received 4-weeks oral treatment of delta-T3 before surgery (200 mg/twice daily) with
personalized nutritional and psychoeducational support. This study evaluates the effects of
treatment on oxidant (tock fast-Li Starfish) and antioxidant capacity (TAC Track, Li
Starfish), anti-inflammatory activity (complete profiling of adaptive and innate cell
immunity, immunologic serum markers (miRNA)), immunological response on tumor (gene
expression profiling on preoperative tissue tumor biopsy and on surgical specimen),
TNF-alpha, IL-6 and VEGF and proliferation/apoptosis, anti-inflammatory and anti-oxidant
activity of breast cancer cell lines.
This study evaluates the effects of treatment on oxidant (tock fast-Li Starfish) and
antioxidant capacity (TAC Track, Li Starfish), on anti-inflammatory activity (complete
profiling of adaptive and innate cell immunity, immunologic serum markers (miRNA)), on
immunological response on tumor (gene expression profiling on preoperative tissue tumor
biopsy and on surgical specimen), on TNF-alpha, IL-6 and VEGF, on proliferation/apoptosis,
anti-inflammatory and anti-oxidant activity of breast cancer cell lines.
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano