Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.
NCT ID: NCT04496492
Last Updated: 2020-08-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-02-09
Study Completion Date
2017-07-06
Brief Summary
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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.
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.
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Detailed Description
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An open-label, single center, phase 2 prospective observational clinical study
Conditions
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Breast Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Tocotrienol
Subjects receiveTocotrienol 200 mg/twice daily before surgery
Group Type
EXPERIMENTAL
Tocotrienol
Intervention Type
DRUG
Tocotrienol 200 mg orally twice a day
Interventions
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Tocotrienol
Tocotrienol 200 mg orally twice a day
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
* absence of distant metastasis
* signed informed consent.
* 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
* 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
Minimum Eligible Age
30 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Cristina Ferraris, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Fondazione IRCCS Istituto Nazionale Tumori
Milan, , Italy
Site Status
Countries
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Italy
References
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Sieri S, Pala V, Brighenti F, Agnoli C, Grioni S, Berrino F, Scazzina F, Palli D, Masala G, Vineis P, Sacerdote C, Tumino R, Giurdanella MC, Mattiello A, Panico S, Krogh V. High glycemic diet and breast cancer occurrence in the Italian EPIC cohort. Nutr Metab Cardiovasc Dis. 2013 Jul;23(7):628-34. doi: 10.1016/j.numecd.2012.01.001. Epub 2012 Apr 10.
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Pasanisi P, Berrino F, De Petris M, Venturelli E, Mastroianni A, Panico S. Metabolic syndrome as a prognostic factor for breast cancer recurrences. Int J Cancer. 2006 Jul 1;119(1):236-8. doi: 10.1002/ijc.21812.
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Villarini A, Pasanisi P, Traina A, Mano MP, Bonanni B, Panico S, Scipioni C, Galasso R, Paduos A, Simeoni M, Bellotti E, Barbero M, Macellari G, Venturelli E, Raimondi M, Bruno E, Gargano G, Fornaciari G, Morelli D, Seregni E, Krogh V, Berrino F. Lifestyle and breast cancer recurrences: the DIANA-5 trial. Tumori. 2012 Jan-Feb;98(1):1-18. doi: 10.1177/030089161209800101.
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Wiseman M. The second World Cancer Research Fund/American Institute for Cancer Research expert report. Food, nutrition, physical activity, and the prevention of cancer: a global perspective. Proc Nutr Soc. 2008 Aug;67(3):253-6. doi: 10.1017/S002966510800712X. Epub 2008 May 1.
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Donini LM, Cuzzolaro M, Spera G, Badiali M, Basso N, Bollea MR, Bosello O, Brunani A, Busetto L, Cairella G, Cannella C, Capodaglio P, Carbonelli MG, Castellaneta E, Castra R, Clini E, Contaldo F, Dalla Ragione L, Dalle Grave R, D'Andrea F, Del Balzo V, De Cristofaro P, Di Flaviano E, Fassino S, Ferro AM, Forestieri P, Franzoni E, Gentile MG, Giustini A, Jacoangeli F, Lubrano C, Lucchin L, Manara F, Marangi G, Marcelli M, Marchesini G, Marri G, Marrocco W, Melchionda N, Mezzani B, Migliaccio P, Muratori F, Nizzoli U, Ostuzzi R, Panzolato G, Pasanisi F, Persichetti P, Petroni ML, Pontieri V, Prosperi E, Renna C, Rovera G, Santini F, Saraceni V, Savina C, Scuderi N, Silecchia G, Strollo F, Todisco P, Tubili C, Ugolini G, Zamboni M. [Obesity and Eating Disorders. Indications for the different levels of care. An Italian Expert Consensus Document]. Eat Weight Disord. 2010 Mar-Jun;15(1-2 Suppl):1-31. Italian.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014-005275-92
Identifier Type: -
Identifier Source: org_study_id
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