Clinical trial · Interventional
A Pilot Clinical Trial With Tocotrienol on Breast Cancer
Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
NCT01157026CI-TRIAL-00003635BCcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Tocotrienol Rich Fraction (TRF) in combination with Tamoxifen will improve breast cancer specific survival and recurrence free survival, in women with early breast cancer and estrogen receptor positive tumors.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo plus tamoxifen | Other | — | UNRESOLVED |
| Tocotrienol Rich Fraction (TRF) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tocotrienol Rich Fraction plus Tamoxifen
- interventionNames
- Dietary Supplement: Tocotrienol Rich Fraction (TRF)
- type
- ACTIVE_COMPARATOR
- label
- Placebo plus tamoxifen
- interventionNames
- Other: placebo plus tamoxifen
Primary outcomes (1)
- measure
- breast cancer specific survival
- timeFrame
- Five Years
- description
- defined as the time from minimization to death due to breast cancer
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion criteria: 1. women with estrogen receptor positive tumors. 2. 40-60 years of age at the start of the tamoxifen therapy. 3. histologically confirmed primary breast cancer. 4. a tumor that was positive for estrogen receptors, progesterone receptors, or both. 5. an Eastern Cooperative Oncology Group performance status of 0,1, or 2 (scored on a scale of 0 to 5, with lower scores indicating better function). Exclusion criteria: 1. concurrent use of investigational drugs and estrogen receptor status negative or unknown.
References
Publications (1)
- DERIVEDNesaretnam K, Selvaduray KR, Abdul Razak G, Veerasenan SD, Gomez PA. Effectiveness of tocotrienol-rich fraction combined with tamoxifen in the management of women with early breast cancer: a pilot clinical trial. Breast Cancer Res. 2010;12(5):R81. doi: 10.1186/bcr2726. Epub 2010 Oct 8. PMID 20929592