Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer

NCT ID: NCT03855423

Last Updated: 2019-04-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Phase Ib: Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women with Breast Cancer is aimed to determine the highest, safest and tolerable dose of Tocotrienol-rich Fraction (maximal tolerated dose: MTD) that can be used in women with breast cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

3+3 step up design method will be used in this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm intervention study 3+3 step up design
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tocotrienol-rich Fraction (TRF)

Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level.

Group Type EXPERIMENTAL

Tocotrienol-rich Fraction (TRF)

Intervention Type DIETARY_SUPPLEMENT

TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tocotrienol-rich Fraction (TRF)

TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tocovid Suprabio

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with operable breast cancer
* Life expectancy of at least 3 months
* Adequate organ function
* No allergy to Vitamin E and TRF
* Provides consent to participate in trial and adhere to the study protocol

Exclusion Criteria

* Receiving concomitant chemotherapy, radiotherapy, hormonal, immune therapy or other investigational drugs
* Uncontrolled concurrent illness
* Pregnant / breast feeding women
* Patients who are unable or unwilling to take Tocotrienols, herbal remedies, or non-prescription medications
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role collaborator

Nur Aishah Mohd Taib

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nur Aishah Mohd Taib

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nur Aishah Taib, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Malaya Medical Center

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Malaysia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nur Aishah Taib, MBBS

Role: CONTACT

+60379493642

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nur Aishah Taib, MBBS

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

853.4

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.