Breast CancerPhase 1NCT00100893
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
A Phase 1 study testing IH636 grape seed proanthocyanidin extract in people with Breast Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IH636 grape seed proanthocyanidin extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Oct 2013
- Phase
- Phase 1
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- At risk of developing breast cancer
- No history of breast cancer or ductal carcinoma in situ
PATIENT CHARACTERISTICS:
Age
- 40 to 75
Sex
- Female
Menopausal status
- Postmenopausal, defined by 1 of the following criteria:
- No spontaneous menses for ≥ 12 months
- Prior bilateral oophorectomy
- Prior hysterectomy with follicle-stimulating hormone within menopausal range
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 100,000/mm^3
- WBC ≥ 3,500/mm^3
- Absolute granulocyte count ≥ 1,500/mm^3
- No coagulation disorders
Hepatic
- SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No major illness of the cardiovascular system
Pulmonary
- No major illness of the respiratory system
Other
- No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer
- No major systemic infection
- No Cushing's syndrome or adrenal insufficiency
- No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol [vitamin D] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- More than 3 months since prior hormone-modifying medications, including any of the following:
- Oral contraceptives
- Hormone replacement therapy
- Selective estrogen receptor modifiers
- Aromatase inhibitors
- Gonadotropin-releasing hormone modifiers
- Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No red wine, red grapes, or white button mushrooms directly before or during study treatment
- White and seedless grapes allowed
- No other concurrent therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
About this study
Official title: A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer.
- Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants.
- Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants.
- Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants.
OUTLINE: This is a pilot, dose-finding, placebo-controlled study.
Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity.
Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose.
PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.
- Conditions
- Breast Cancer
- Being tested
- IH636 grape seed proanthocyanidin extract
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IH636 grape seed proanthocyanidin extractDietary supplement
Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: grape seed proanthocyanidin extract | Experimental | Administered orally. Receives: Dietary Supplement: IH636 grape seed proanthocyanidin extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
Measured: at 1, 2, 4, 8, and 12 weeks
Secondary outcomes (5)
Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)
Measured: at 1, 2, 4, 8, and 12 weeks
Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides
Measured: at 12 weeks
Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides
Measured: at 12 weeks
Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)
Measured: at 12 weeks
Pharmacokinetics as measured by procyanidins
Measured: before and after first dose and then at 1, 2, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2005 (estimated)
- Study startJan 2005
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100893
- Sponsor's protocol ID
- 03178
- Other IDs
- P30CA033572, CHNMC-IRB-03178, CDR0000407637
- Status last verified
- Jun 2015
- First submitted
- 6 Jan 2005
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer
- ClinicalTrials.gov ID
- NCT00100893
- Acronym / sponsor ID
- 03178
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2005
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jan 2005 (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.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer.
- Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants.
- Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants.
- Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants.
OUTLINE: This is a pilot, dose-finding, placebo-controlled study.
Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity.
Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose.
PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: grape seed proanthocyanidin extract | Experimental | Dietary Supplement: IH636 grape seed proanthocyanidin extractAdministered orally. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| IH636 grape seed proanthocyanidin extractDose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage | Dietary supplement | Dietary Supplement: grape seed proanthocyanidin extract |
Primary outcome
Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin
Time frame: at 1, 2, 4, 8, and 12 weeks
5 secondary outcomes
Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)
Time frame: at 1, 2, 4, 8, and 12 weeks
Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides
Time frame: at 12 weeks
Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides
Time frame: at 12 weeks
Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)
Time frame: at 12 weeks
Pharmacokinetics as measured by procyanidins
Time frame: before and after first dose and then at 1, 2, 4, 8, and 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 8 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IH636 grape seed proanthocyanidin extract in people with Breast Cancer, run by City of Hope Medical Center 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?
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 8 Jun 2015. 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.
What does this 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.
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?
Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin (time frame: at 1, 2, 4, 8, and 12 weeks). 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 8 Jun 2015.