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

Breast Cancer Clinical Trial

— TOCANNATO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496492
• Other study ID #: 2014-005275-92
• Status: Completed
• Phase: Phase 2
• Start date: February 9, 2016
• Est. completion date: July 6, 2017

Study information

• Verified date: June 2020
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 6, 2017
• Est. primary completion date: February 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tocotrienol
Tocotrienol 200 mg orally twice a day

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

References & Publications (74)

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* Note: There are 74 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in blood oxidant capacity	Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.	4 weeks
Primary	Changes in blood antioxidant capacity	Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.	4 weeks
Primary	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
Primary	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
Primary	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
Primary	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	Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines	Treatment-induced changes in proliferation/apoptosis, anti-inflammatory and anti-oxidant activity of breast cancer cell lines was measured through cell culture analysis.	12,24 and 72 hours
Secondary	Changes in expression of tumor proliferation, hormone receptors and HER2	Expression of tumor proliferation index (Ki67), estrogen and/progesterone receptor and HER2 oncoprotein by IHC was determined in preoperative tumor biopsies and in surgical specimens	4 weeks