Breast Cancer FemaleMatriacNCT03855423
Maximum Tolerated Dose, Safety and Pharmacologic Study of TRF in Women With Breast Cancer
A study testing Tocotrienol-rich Fraction (TRF) in people with Breast Cancer Female, run by Nur Aishah Mohd Taib at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Tocotrienol-rich Fraction (TRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Feb 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University of Malaya Medical Center
Kuala Lumpur
Nur Aishah Taib, MBBS
About this study
Official title: Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
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.
Read the detailed description
3+3 step up design method will be used in this study.
- Conditions
- Breast Cancer Female
- Being tested
- Tocotrienol-rich Fraction (TRF)
- Keywords
- MTD, TRF, Pharmacology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol-rich Fraction (TRF)Dietary supplement
Also called Tocovid Suprabio
TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol
| Study group | Role | What they receive |
|---|---|---|
| Tocotrienol-rich Fraction (TRF) | Experimental | Pre-operative patients will be receiving TRF at different doses assigned to them in a cohort of 3 patients at each level. Receives: Dietary Supplement: Tocotrienol-rich Fraction (TRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Assessment
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Measured: For 2 to 4 weeks during supplementation
Liver Function Test
Liver enzymes with units of U/L
Measured: For 2 to 4 weeks during supplementation
Secondary outcomes (1)
Bioavailability of TRF
Blood pharmacokinetic parameters
Measured: For 2 to 4 weeks during supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start18 Feb 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm intervention study 3+3 step up design
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nur Aishah Mohd Taib
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Responsible party
- Sponsor-investigator, Nur Aishah Mohd Taib, University of Malaya
- Investigators
- Nur Aishah Taib, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855423
- Sponsor's protocol ID
- 853.4
- Acronym
- Matriac
- Status last verified
- Apr 2019
- First submitted
- 14 Feb 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malaysian Tocotrienol Rich Fraction: Immunomodulatory Effect in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT03855423
- Acronym / sponsor ID
- Matriac / 853.4
- Conditions
- Breast Cancer Female
- Keywords
- MTD, TRF, Pharmacology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nur Aishah Mohd TaibUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
3+3 step up design method will be used in this study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm intervention study 3+3 step up design
| Arm | Type | Receives |
|---|---|---|
| Tocotrienol-rich Fraction (TRF) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocotrienol-rich Fraction (TRF)Also: Tocovid SuprabioTRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol | Dietary supplement | Tocotrienol-rich Fraction (TRF) |
Primary outcome
Physical Assessment
Time frame: For 2 to 4 weeks during supplementation
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Liver Function Test
Time frame: For 2 to 4 weeks during supplementation
Liver enzymes with units of U/L
1 secondary outcome
Bioavailability of TRF
Time frame: For 2 to 4 weeks during supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nur Aishah Taib, MBBS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocotrienol-rich Fraction (TRF) in people with Breast Cancer Female, run by Nur Aishah Mohd Taib at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nur Aishah Taib, MBBS (+60379493642, nuraish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Assessment (time frame: For 2 to 4 weeks during supplementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.