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

NCT04496492 | Completed Phase 2

• 1 other identifier: 2014-005275-92
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Changes in blood oxidant capacity

  Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.

  4 weeks

• Changes in blood antioxidant capacity

  Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.

  4 weeks

• Absolute and relative changes in peripheral blood mononuclear cells obtained before and after four weeks of tocotrienol treatment, as detected by 13-colors citofluorimetry analysis

  Peripheral blood mononuclear cells were measured by 13-color cytofluorimetry analysis in patients' serum samples.

  4 weeks

• Changes of immune-related miRNA levels in patients' serum samples obtained before and after four weeks of tocotrienol treatment, as determined by quantitative real-time PCR analysis

  Immune-related miRNA levels were determined by quantitative real-time PCR analysis in patients' serum samples obtained before and after four weeks of tocotrienol treatment

  4 weeks

• Changes in immune response associated gene levels in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment, respectively, as determined by gene expression profiling analysis

  Immune response associated gene levels were determined by gene expression profiling analysis in preoperative tissue tumor biopsies and in surgical specimens, obtained before and after four weeks of tocotrienol treatment

  4 weeks

• Changes in serum inflammatory cytokines and growth factor

  Blood inflammatory cytokines and growth factor (through TNF-alpha (pg/ml), IL-6 (pg/ml) and VEGF (pg/ml) quantifications) were measured in patients' serum samples

  4 weeks

Secondary Outcomes (2)

• Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines

  12,24 and 72 hours

• Changes in expression of tumor proliferation, hormone receptors and HER2

  4 weeks

Study Arms (1)

Tocotrienol

EXPERIMENTAL

Subjects receiveTocotrienol 200 mg/twice daily before surgery

Drug: Tocotrienol

Interventions

Tocotrienol DRUG

Tocotrienol 200 mg orally twice a day

Tocotrienol

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tocotrienols

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cristina Ferraris, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: August 3, 2020
• Study Start: February 9, 2016
• Primary Completion: February 9, 2016
• Study Completion: July 6, 2017
• Last Updated: August 3, 2020

Record last verified: 2020-06

Locations

IT (1)