NCT04496492

Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.

Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An open-label, single center, phase 2 prospective observational clinical study

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tocotrienol	Tocotrienol 200 mg orally twice a day

Timeline

• Start date: 2016-02-09
• Primary completion: 2016-02-09
• Completion: 2017-07-06
• First posted: 2020-08-03
• Last updated: 2020-08-03

Locations

1 site across 1 country: Italy