Breast CancerNCT00566553
The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women
A study testing Grape Seed Extract in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Grape Seed Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2011
- 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 55 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55 - 75 years
- Able to understand and sign a consent form
- Postmenopausal (no menstrual period for 1 year or more)
- No personal cancer history (except for non-melanoma skin cancer)
- No hormone replacement therapy or anti-estrogens within 6 months of baseline
Who cannot join
- Known allergy to grapes or grape products
- Currently on ACE inhibitors, methotrexate, allopurinol, coumadin (Warfarin, Jantoven), heparin, clopidogrel (Plavix), or cholesterol lowering medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study
The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.
Read the detailed description
Early detection of breast cancer with screening mammography and the use of more effective medical therapies have led to a decrease in breast cancer mortality. However, breast cancer is still the second leading cause of cancer death in women (2). Therefore, the future lies in not only early detection but prevention of breast cancer. Currently available chemopreventive agents are associated with potentially serious side effects and can be quite costly, especially when taken for extended periods of time. Therefore, they are usually targeted only to women at high risk of disease. Identification of an inexpensive, efficacious preventive therapy with few or no side effects would represent a major advance in reducing the morbidity and mortality due to breast cancer. One exciting possibility is grape seed extract. Grapes and grape seeds contain procyanidins, a highly active subclass of flavonoids with actions similar to pharmaceutical aromatase inhibitors (AIs). These procyanidin dimers have been found to suppress estrogen biosynthesis both in vitro and in animal models (1). Based upon this knowledge we proposed this dose finding pilot study.
- Conditions
- Breast Cancer
- Being tested
- Grape Seed Extract
- Keywords
- Grape Seed Extract, Breast Cancer, Estrogen Levels, Aromatase Inhibitor
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grape Seed ExtractDietary supplement
Also called ActiVin®
200 mg dose daily for 12 weeks.
Grape Seed ExtractDietary supplement
Also called ActiVin®
400 mg dose daily for 12 weeks.
Grape Seed ExtractDietary supplement
Also called ActiVin®
600 mg dose daily for 12 weeks.
Grape Seed ExtractDietary supplement
Also called ActiVin®
800 mg dose daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Grape Seed Extract # 1 | Active comparator | 200 mg [1 pill] Receives: Dietary Supplement: Grape Seed Extract |
| Grape Seed Extract # 2 | Active comparator | 200 mg [2 pills] Receives: Dietary Supplement: Grape Seed Extract |
| Grape Seed Extract # 3 | Active comparator | 200 mg [3 pills] Receives: Dietary Supplement: Grape Seed Extract |
| Grape Seed Extract # 4 | Active comparator | 200 mg [4 pills] Receives: Dietary Supplement: Grape Seed Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document that grape seed extract taken orally will decrease plasma estrogen levels (estrone (E1), estradiol (E2), and E1-conjugates) and increase precursor androgen levels (testosterone and androstenedione) in healthy postmenopausal women.
Measured: 12 weeks
Secondary outcomes (1)
To determine the most effective, well tolerated dose of grape seed extract resulting in a decrease in plasma estrogen levels (E1, E2, E1-conjugates) and increase in precursor androgens (testosterone and androstenedione).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dietlind Wahner-Roedler, Mayo Clinic
- Investigators
- Dietlind L. Wahner-Roedler, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566553
- Sponsor's protocol ID
- 06-009628
- Status last verified
- Jan 2012
- First submitted
- 30 Nov 2007
- Last updated
- 6 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Eng ET, Ye J, Williams D, Phung S, Moore RE, Young MK, Gruntmanis U, Braunstein G, Chen S. Suppression of estrogen biosynthesis by procyanidin dimers in red wine and grape seeds. Cancer Res. 2003 Dec 1;63(23):8516-22.
PubMed 14679019American Cancer Society. Cancer Facts and Figures 2005. Atlanta, GA: American Cancer Society; 2005.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Grape Seed Extract on Estrogen Levels of Postmenopausal Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT00566553
- Acronym / sponsor ID
- 06-009628
- Conditions
- Breast Cancer
- Keywords
- Grape Seed Extract, Breast Cancer, Estrogen Levels, Aromatase Inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Dec 2007 (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 role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.
Detailed description
Early detection of breast cancer with screening mammography and the use of more effective medical therapies have led to a decrease in breast cancer mortality. However, breast cancer is still the second leading cause of cancer death in women (2). Therefore, the future lies in not only early detection but prevention of breast cancer. Currently available chemopreventive agents are associated with potentially serious side effects and can be quite costly, especially when taken for extended periods of time. Therefore, they are usually targeted only to women at high risk of disease. Identification of an inexpensive, efficacious preventive therapy with few or no side effects would represent a major advance in reducing the morbidity and mortality due to breast cancer. One exciting possibility is grape seed extract. Grapes and grape seeds contain procyanidins, a highly active subclass of flavonoids with actions similar to pharmaceutical aromatase inhibitors (AIs). These procyanidin dimers have been found to suppress estrogen biosynthesis both in vitro and in animal models (1). Based upon this knowledge we proposed this dose finding pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Grape Seed Extract # 1 | Active comparator | Dietary Supplement: Grape Seed Extract200 mg [1 pill] |
| Grape Seed Extract # 2 | Active comparator | Dietary Supplement: Grape Seed Extract200 mg [2 pills] |
| Grape Seed Extract # 3 | Active comparator | Dietary Supplement: Grape Seed Extract200 mg [3 pills] |
| Grape Seed Extract # 4 | Active comparator | Dietary Supplement: Grape Seed Extract200 mg [4 pills] |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 55 - 75 years
- Able to understand and sign a consent form
- Postmenopausal (no menstrual period for 1 year or more)
- No personal cancer history (except for non-melanoma skin cancer)
- No hormone replacement therapy or anti-estrogens within 6 months of baseline
Key exclusion criteria (2 listed)
- Known allergy to grapes or grape products
- Currently on ACE inhibitors, methotrexate, allopurinol, coumadin (Warfarin, Jantoven), heparin, clopidogrel (Plavix), or cholesterol lowering medication
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 |
|---|---|---|
| Grape Seed ExtractAlso: ActiVin®200 mg dose daily for 12 weeks. | Dietary supplement | Grape Seed Extract # 1 |
| Grape Seed ExtractAlso: ActiVin®400 mg dose daily for 12 weeks. | Dietary supplement | Grape Seed Extract # 2 |
| Grape Seed ExtractAlso: ActiVin®600 mg dose daily for 12 weeks. | Dietary supplement | Grape Seed Extract # 3 |
| Grape Seed ExtractAlso: ActiVin®800 mg dose daily for 12 weeks. | Dietary supplement | Grape Seed Extract # 4 |
Primary outcome
To document that grape seed extract taken orally will decrease plasma estrogen levels (estrone (E1), estradiol (E2), and E1-conjugates) and increase precursor androgen levels (testosterone and androstenedione) in healthy postmenopausal women.
Time frame: 12 weeks
1 secondary outcome
To determine the most effective, well tolerated dose of grape seed extract resulting in a decrease in plasma estrogen levels (E1, E2, E1-conjugates) and increase in precursor androgens (testosterone and androstenedione).
Time frame: 12 weeks
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 6 Jan 2012.
- Background: PubMed 14679019Eng ET, Ye J, Williams D, Phung S, Moore RE, Young MK, Gruntmanis U, Braunstein G, Chen S. Suppression of estrogen biosynthesis by procyanidin dimers in red wine and grape seeds. Cancer Res. 2003 Dec 1;63(23):8516-22.
- BackgroundAmerican Cancer Society. Cancer Facts and Figures 2005. Atlanta, GA: American Cancer Society; 2005.
- American Cancer Society. Cancer Facts \& Figures 2005.Link provided by the sponsor.
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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.
Dietlind L. Wahner-Roedler, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Grape Seed Extract in people with Breast Cancer, run by Mayo Clinic at 1 site in United States.
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 2 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 6 Jan 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 United States. 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?
To document that grape seed extract taken orally will decrease plasma estrogen levels (estrone (E1), estradiol (E2), and E1-conjugates) and increase precursor androgen levels (testosterone and androstenedione) in healthy postmenopausal women. (time frame: 12 weeks). 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 NCT00566553, which also lists 2 linked publications.
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 6 Jan 2012.