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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.
An open-label, single center, phase 2 prospective observational clinical study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocotrienol | Experimental | Subjects receiveTocotrienol 200 mg/twice daily before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienol | Drug | Tocotrienol 200 mg orally twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Ferraris, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale Tumori | Milan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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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 |
| 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 |
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| 22495696 | Result | 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. |
| 18452640 | Result | 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. |
| 20975326 | Result | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |