Status:
COMPLETED
Preoperative Use of Tocotrienol From Annatto Bixa Orellana L. in Breast Cancer Patients: a Prospective Clinical Trial.
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Breast Cancer
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
Brief 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 exp...
Detailed Description
An open-label, single center, phase 2 prospective observational clinical study
Eligibility Criteria
Inclusion
- histologically confirmed operable primary breast cancer (T1-T2 N0-1 M0)
- absence of distant metastasis
- signed informed consent.
Exclusion
- 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
Key Trial Info
Start Date :
February 9 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04496492
Start Date
February 9 2016
End Date
July 6 2017
Last Update
August 3 2020
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy, 20133