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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Tocotrienol

Study type

Interventional

Funder types

Other

Identifiers

NCT04496492

2014-005275-92

Details and patient eligibility

About

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.

Full description

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

Enrollment

50 patients

Sex

All

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
absence of distant metastasis
signed informed consent.

Exclusion criteria

Previous malignancies other than in situ cervical carcinoma or nonmelanoma skin cancer
Breast cancer recurrence
Metastatic breast cancer
Non-epithelial breast cancer at histological examination
In situ lobular breast cancer
Participation in other randomized clinical trials that could interfere with current study
Living distant from center and unable to attend for check-ups and meetings