Breast CancerBCNCT01157026
A Pilot Clinical Trial With Tocotrienol on Breast Cancer
A study testing Tocotrienol Rich Fraction (TRF) in people with Breast Cancer, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tocotrienol Rich Fraction (TRF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2001to Jan 2010
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with estrogen receptor positive tumors.
- 40-60 years of age at the start of the tamoxifen therapy.
- histologically confirmed primary breast cancer.
- a tumor that was positive for estrogen receptors, progesterone receptors, or both.
- 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).
Who cannot join
- concurrent use of investigational drugs and estrogen receptor status negative or unknown.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
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.
Read the detailed description
We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E.
- Conditions
- Breast Cancer
- Being tested
- Tocotrienol Rich Fraction (TRF), placebo plus tamoxifen
- Keywords
- Breast cancer, Tocotrienol-rich fraction with tamoxifen
- Medical subject headings
- Breast Neoplasms
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 Tocotrienol Rich Fraction (Hovid Sdn.Bhd)
Tocotrienol Rich Fraction (200mg), daily for five years
placebo plus tamoxifenOther
20mg tamoxifen daily
| Study group | Role | What they receive |
|---|---|---|
| Tocotrienol Rich Fraction plus Tamoxifen | Experimental | Not described Receives: Dietary Supplement: Tocotrienol Rich Fraction (TRF) |
| Placebo plus tamoxifen | Active comparator | Not described Receives: Other: placebo plus tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
breast cancer specific survival
defined as the time from minimization to death due to breast cancer
Measured: Five Years
Secondary outcomes (1)
disease free survival
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startNov 2001
- Primary completionNov 2006
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Investigators
- Kalanithi Nesaretnam, PhD, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157026
- Sponsor's protocol ID
- CT369
- Other IDs
- 5399 S1
- Acronym
- BC
- Status last verified
- Jul 2010
- First submitted
- 1 Jul 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Nesaretnam 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.
PubMed 20929592
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tocotrienol-rich Fraction Combined With Tamoxifen in the Management of Women With Early Breast Cancer: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT01157026
- Acronym / sponsor ID
- BC / CT369
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Tocotrienol-rich fraction with tamoxifen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Study start
- Nov 2001
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Jul 2010 (estimated)
- 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.
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.
Detailed description
We conducted a, double-blinded, placebo controlled trial of TRF plus tamoxifen versus placebo plus tamoxifen in women with primary breast cancer for five years. Both the TRF and placebo drugs were prepared and supplied by Hovid Sdn Bhd, Malaysia. Hovid Sdn. Bhd. absolutely did not have any influence in the trial designing, patient recruitment, data collection, analysis and reporting. The placebo drug which contained soy oil without tocotrienols had similar appearance and taste as the TRF drug. A total of 240 women breast cancer patients were assigned to two groups by minimization method that balanced treatment groups. The intervention group was given TRF plus tamoxifen, (n = 120) while control group was given placebo plus tamoxifen, (n = 120). The primary end point was breast cancer specific survival, defined as the time from minimization to death due to breast cancer. The secondary end points included disease free survival, biochemical parameters, liver function and plasma levels of vitamin E.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocotrienol Rich Fraction plus Tamoxifen | Experimental | Dietary Supplement: Tocotrienol Rich Fraction (TRF) |
| Placebo plus tamoxifen | Active comparator | Other: placebo plus tamoxifen |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women with estrogen receptor positive tumors.
- 40-60 years of age at the start of the tamoxifen therapy.
- histologically confirmed primary breast cancer.
- a tumor that was positive for estrogen receptors, progesterone receptors, or both.
- 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).
Key exclusion criteria (1 listed)
- concurrent use of investigational drugs and estrogen receptor status negative or unknown.
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: Tocotrienol Rich Fraction (Hovid Sdn.Bhd)Tocotrienol Rich Fraction (200mg), daily for five years | Dietary supplement | Tocotrienol Rich Fraction plus Tamoxifen |
| placebo plus tamoxifen20mg tamoxifen daily | Other | Placebo plus tamoxifen |
Primary outcome
breast cancer specific survival
Time frame: Five Years
defined as the time from minimization to death due to breast cancer
1 secondary outcome
disease free survival
Time frame: Five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
- Derived from this study: PubMed 20929592Nesaretnam 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.
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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.
Kalanithi Nesaretnam, PhD principal investigator
Malaysia Palm Oil Board
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, run by Malaysia Palm Oil Board 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 1 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: finished, as of the sponsor's last update on 5 Jul 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breast cancer specific survival (time frame: Five Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157026, which also lists 1 linked publication.
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 5 Jul 2010.