Breast CancerPhase 1/2NCT01089049
Effect of a Natural Health Product on Urinary Estrogen Metabolites
A Phase 1/2 study testing FemMED Breast Health Formula in people with Breast Cancer, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- FemMED Breast Health Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to May 2010
- Phase
- Phase 1/2
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Healthy
- Willing to collect urine samples and to have blood drawn
- Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects)
- Pre-menopausal (48 subjects)
Who cannot join
- Diagnosed with any major illness(e.g. cancer)
- Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura"
- Women taking blood thinner or thyroid medication (including warfarin)
- Known allergy to any of the any of the study ingredients
- Pregnancy or lactation
- Regular consumption in the previous 3 months of any other natural health products (NHPs) or pharmaceutical containing ingredients with a similar effect on estrogen metabolism as those included in the femMED Breast Health treatment
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- Family history of breast cancer risk
- Post-menopausal women on HRT
- Pre-menopausal women taking hormonal contraceptives (oral contraceptives, the patch etc.)
- All other forms of estrogen, progesterone and/or androgens (i.e. testosterone therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Assess the Efficacy of a Supplemental Formula Targeting Breast Health in Beneficially Altering Urinary Estrogen Metabolites Levels in Both Pre- and Post-menopausal Women
The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites.
Read the detailed description
The active botanical constituents in femMED Breast Health Formula contain lignans, compounds with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the follicular phase [i.e. when estrogen is low] and an antiestrogenic effect in the luteal phase of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of estrogen in the body. Overall these compounds have been found to be helpful in stabilizing the natural cyclical fluctuation of estrogen levels.
The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects will be recruited to one of two arms of the study: one arm will consist of pre-menopausal women; another will consist of post-menopausal women. Each arm of the study will be carried out concurrently and in one phase, with no washout period. The placebo assignment will be randomized within each arm of the study.
Subjects in each arm of the study will follow the same protocol. Urine and blood samples will be collected from each group at both the first and last visit, and subjects will receive a month's supply of treatment or placebo at the first visit, which they will consume on a daily basis until their second lab visit 28 days later. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be collected and assessed for levels of enterolactone. Pre and post-supplementation results will be assesses for any differences by statistical comparison.
- Conditions
- Breast Cancer
- Being tested
- FemMED Breast Health Formula
- Keywords
- Urinary Estrogen Metabolites, 2-OH Estrone, 16-alpha-OH Estrone, Urinary 2/16a Estrogen Metabolite Ratio
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FemMED Breast Health FormulaDietary supplement
Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Menopausal | Experimental | Not described Receives: Dietary Supplement: FemMED Breast Health Formula |
| Post-Menopausal | Experimental | Not described Receives: Dietary Supplement: FemMED Breast Health Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-OH Hydroxy Estrone: 16-alpha-OH Estrone
2-OHE:16α-OHE1 (2:16 ratio) - 2:16 ratios less than 2.0 indicate increasing long-term risk for breast, cervical, and other estrogen sensitive cancers.
Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone.
Measured: Day 0, Day 28
Secondary outcomes (1)
Enterolactone
Enterolactone is a lignan formed by the action of intestinal bacteria on lignan precursors found in plants. For the purpose of this study, enterolactone will serve as an indicator of compliance/dietary intake of lignans.
Blood samples would be collected and assessed for levels of enterolactone.
Measured: Day 0, Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionMay 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Maggie Laidlaw, P.hD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089049
- Sponsor's protocol ID
- NDI: 136987
- Other IDs
- NHPD136987
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2010
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Laidlaw M, Cockerline CA, Sepkovic DW. Effects of a breast-health herbal formula supplement on estrogen metabolism in pre- and post-menopausal women not taking hormonal contraceptives or supplements: a randomized controlled trial. Breast Cancer (Auckl). 2010 Dec 16;4:85-95. doi: 10.4137/BCBCR.S6505.
PubMed 21234288
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Efficacy of a Supplemental Formula Targeting Breast Health in Beneficially Altering Urinary Estrogen Metabolites Levels in Both Pre- and Post-menopausal Women
- ClinicalTrials.gov ID
- NCT01089049
- Acronym / sponsor ID
- NDI: 136987
- Conditions
- Breast Cancer
- Keywords
- Urinary Estrogen Metabolites, 2-OH Estrone, 16-alpha-OH Estrone, Urinary 2/16a Estrogen Metabolite Ratio
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Research network
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 18 Mar 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.
The purpose of this study is to determine if a supplemental formula can beneficially alter the ratio of urinary estrogen metabolites.
Detailed description
The active botanical constituents in femMED Breast Health Formula contain lignans, compounds with anti-estrogenic activity, that have been shown to exert an estrogenic effect during the follicular phase [i.e. when estrogen is low] and an antiestrogenic effect in the luteal phase of a female menstrual cycle. These are plant-derived chemicals that can act as weak mimics of estrogen in the body. Overall these compounds have been found to be helpful in stabilizing the natural cyclical fluctuation of estrogen levels.
The trial will be a double-blind, placebo-controlled parallel study in which 100 subjects will be recruited to one of two arms of the study: one arm will consist of pre-menopausal women; another will consist of post-menopausal women. Each arm of the study will be carried out concurrently and in one phase, with no washout period. The placebo assignment will be randomized within each arm of the study.
Subjects in each arm of the study will follow the same protocol. Urine and blood samples will be collected from each group at both the first and last visit, and subjects will receive a month's supply of treatment or placebo at the first visit, which they will consume on a daily basis until their second lab visit 28 days later. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone. Blood samples would be collected and assessed for levels of enterolactone. Pre and post-supplementation results will be assesses for any differences by statistical comparison.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Menopausal | Experimental | Dietary Supplement: FemMED Breast Health Formula |
| Post-Menopausal | Experimental | Dietary Supplement: FemMED Breast Health Formula |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Healthy
- Willing to collect urine samples and to have blood drawn
- Post-menopausal and have not taken hormone replacement therapy (HRT) in the past year (48 subjects)
- Pre-menopausal (48 subjects)
Key exclusion criteria (10 listed)
- Diagnosed with any major illness(e.g. cancer)
- Diabetes, thyroid disease, atypical hyperplasia, fibrocystic breast disease, family history of ovarian cancer, a history of "migraines with aura"
- Women taking blood thinner or thyroid medication (including warfarin)
- Known allergy to any of the any of the study ingredients
- Pregnancy or lactation
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 |
|---|---|---|
| FemMED Breast Health FormulaTwo capsules daily, with meals. FemMED Breast Health Formula containing lignans. | Dietary supplement | Post-Menopausal, Pre-Menopausal |
Primary outcome
2-OH Hydroxy Estrone: 16-alpha-OH Estrone
Time frame: Day 0, Day 28
2-OHE:16α-OHE1 (2:16 ratio) - 2:16 ratios less than 2.0 indicate increasing long-term risk for breast, cervical, and other estrogen sensitive cancers. Urine samples will be analyzed for the following estrogen metabolites: 2-OH-estrone and 16-α OH-estrone.
1 secondary outcome
Enterolactone
Time frame: Day 0, Day 28
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 26 Mar 2012.
- Derived from this study: PubMed 21234288Laidlaw M, Cockerline CA, Sepkovic DW. Effects of a breast-health herbal formula supplement on estrogen metabolism in pre- and post-menopausal women not taking hormonal contraceptives or supplements: a randomized controlled trial. Breast Cancer (Auckl). 2010 Dec 16;4:85-95. doi: 10.4137/BCBCR.S6505.
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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.
Maggie Laidlaw, P.hD principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FemMED Breast Health Formula in people with Breast Cancer, run by Nutrasource Pharmaceutical and Nutraceutical Services, Inc. at 1 site in Canada.
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 10 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 26 Mar 2012. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
2-OH Hydroxy Estrone: 16-alpha-OH Estrone (time frame: Day 0, Day 28). 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 NCT01089049, 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 26 Mar 2012.