Clinical trial · Interventional
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.
Preoperative Use of Tocotrienol Associated With Personalized Nutritional and Psychoeducational Support in Women With Primary Breast Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tocotrienol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tocotrienol
- description
- Subjects receiveTocotrienol 200 mg/twice daily before surgery
- interventionNames
- Drug: Tocotrienol
Primary outcomes (6)
- measure
- Changes in blood oxidant capacity
- timeFrame
- 4 weeks
- description
- Oxidant capacity (through tock fast-Li Starfish) (µmol/L) was measured in patients' serum samples.
- measure
- Changes in blood antioxidant capacity
- timeFrame
- 4 weeks
- description
- Antioxidant capacity (through TAC Track, Li Starfish) (µmol/L) was measured in patients' serum samples.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (74)
- RESULTQureshi AA, Pearce BC, Nor RM, Gapor A, Peterson DM, Elson CE. Dietary alpha-tocopherol attenuates the impact of gamma-tocotrienol on hepatic 3-hydroxy-3-methylglutaryl coenzyme A reductase activity in chickens. J Nutr. 1996 Feb;126(2):389-94. doi: 10.1093/jn/126.2.389. PMID 8632210
- RESULTRasool AH, Rahman AR, Yuen KH, Wong AR. Arterial compliance and vitamin E blood levels with a self emulsifying preparation of tocotrienol rich vitamin E. Arch Pharm Res. 2008 Sep;31(9):1212-7. doi: 10.1007/s12272-001-1291-5. Epub 2008 Sep 20. PMID 18806966
- RESULTSong BL, DeBose-Boyd RA. Insig-dependent ubiquitination and degradation of 3-hydroxy-3-methylglutaryl coenzyme a reductase stimulated by delta- and gamma-tocotrienols. J Biol Chem. 2006 Sep 1;281(35):25054-61. doi: 10.1074/jbc.M605575200. Epub 2006 Jul 10. PMID 16831864
- RESULTPearce BC, Parker RA, Deason ME, Qureshi AA, Wright JJ. Hypocholesterolemic activity of synthetic and natural tocotrienols. J Med Chem. 1992 Oct 2;35(20):3595-606. doi: 10.1021/jm00098a002. PMID 1433170
- RESULTBegum AN, Terao J. Protective effect of alpha-tocotrienol against free radical-induced impairment of erythrocyte deformability. Biosci Biotechnol Biochem. 2002 Feb;66(2):398-403. doi: 10.1271/bbb.66.398. PMID 11999415
- RESULTPalozza P, Verdecchia S, Avanzi L, Vertuani S, Serini S, Iannone A, Manfredini S. Comparative antioxidant activity of tocotrienols and the novel chromanyl-polyisoprenyl molecule FeAox-6 in isolated membranes and intact cells. Mol Cell Biochem. 2006 Jul;287(1-2):21-32. doi: 10.1007/s11010-005-9020-7. Epub 2006 Apr 28. PMID 16645729
- RESULTPacker L, Weber SU, Rimbach G. Molecular aspects of alpha-tocotrienol antioxidant action and cell signalling. J Nutr. 2001 Feb;131(2):369S-73S. doi: 10.1093/jn/131.2.369S.