Breast CancerNCT00036686
Isoflavones in Treating Women Who Have Breast Cancer and Are Planning to Undergo Mastectomy or Lumpectomy
A study testing Soy protein isolate in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 7 sites in United States.
Trial summary
RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of 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
- What is being tested?
- Soy protein isolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2002to Mar 2003
- 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
DISEASE CHARACTERISTICS:
- Undergoing breast biopsy for any stage breast cancer
- No excisional biopsy
- At least one core biopsy block must contain carcinoma
- Definitive surgery (mastectomy or lumpectomy) planned for 2-4 weeks after registration to this study
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Premenopausal
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No known prior hepatic disease
Renal:
- No known prior renal disease
Other:
- Not pregnant or nursing
- Fertile patients must use effective non-hormonal contraception
- No other prior malignancy except nonmelanoma skin cancer
- No known prior thyroid disease
- No adherence to vegan diet or other special dietary requirements that would preclude study participation
- No allergy to study agent
- No obesity (body mass index greater than 32)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent birth control pills or other hormonal therapy
- No concurrent thyroid hormone replacement medications
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- More than 30 days since prior antibiotics
- More than 4 weeks since prior soy products
- No routine consumption of greater than 40 mg of soy/day
- No other concurrent nutritional supplements, including modular supplements of other isoflavones
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726
Coastal Hematology and Oncology, P.C. - Savannah
Savannah, Georgia, 31406
St. John's Regional Health Center
Springfield, Missouri, 65804-2263
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
The Bronx, New York, 10466
About this study
Official title: A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
RATIONALE: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer.
PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.
Read the detailed description
OBJECTIVES:
- Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
- Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
- Correlate changes in serum isoflavones with changes in cell proliferation, apoptosis, and hormonal levels in patients treated with this therapy.
- Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery (follicular phase [i.e., during first 7 days of menstrual cycle] vs luteal phase [i.e., after day 7 of the menstrual cycle]). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
- Arm II:Patients receive oral placebo twice daily and oral multivitamins once daily.
In both arms, treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 18 months.
- Conditions
- Breast Cancer
- Being tested
- Soy protein isolate, Placebo
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer, stage IV 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.
Soy protein isolateDietary supplement
Also called isoflavones
Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
PlaceboOther
Arm II: Patients receive oral placebo twice daily and oral multivitamins once daily.
| Study group | Role | What they receive |
|---|---|---|
| Soy protein isolate | Experimental | Administration Prior to Mastectomy or Lumpectomy.
Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. Receives: Dietary Supplement: Soy protein isolate |
| Placebo | Placebo comparator | Administration Prior to Mastectomy or Lumpectomy.
Patients receive oral placebo twice daily and oral multivitamins once daily.
Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Soy Protein Isolate Effect
Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
Measured: 1 Year
Secondary outcomes (1)
Occurrence of Effect on Serum Isoflavone Levels
Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2002
- Primary completionMar 2003
- Study completionMar 2003
Why it stopped: low accrual
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 H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Double blind
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nagi B. Kumar, PhD, RD, FADA, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036686
- Sponsor's protocol ID
- MCC-13021
- Other IDs
- NCI-5348, NCI-P02-0214, 0104
- Status last verified
- Sep 2012
- First submitted
- 13 May 2002
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of the Action of Isoflavones in Breast Neoplasia: Administration Prior to Mastectomy or Lumpectomy-A Pilot Study
- ClinicalTrials.gov ID
- NCT00036686
- Acronym / sponsor ID
- MCC-13021
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, recurrent breast cancer, stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2002
- Primary completion
- Mar 2003 (actual)
- Study completion
- Mar 2003 (actual)
- First posted
- 27 Jan 2003 (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: Eating a diet rich in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of breast cancer cells and prevent further development of breast cancer.
PURPOSE: Randomized pilot trial to study the effectiveness of isoflavones in preventing further development of breast cancer in women who are planning to undergo mastectomy or lumpectomy.
Detailed description
OBJECTIVES:
- Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
- Determine the effect of soy protein isolate on serum isoflavone levels in these patients.
- Correlate changes in serum isoflavones with changes in cell proliferation, apoptosis, and hormonal levels in patients treated with this therapy.
- Correlate the changes in cell proliferation and apoptosis with hormonal markers in patients treated with this therapy.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to the phase of the menstrual cycle at time of biopsy and time of surgery (follicular phase [i.e., during first 7 days of menstrual cycle] vs luteal phase [i.e., after day 7 of the menstrual cycle]). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily.
- Arm II:Patients receive oral placebo twice daily and oral multivitamins once daily.
In both arms, treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure.
PROJECTED ACCRUAL: A total of 106 patients (53 per treatment arm) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy protein isolate | Experimental | Dietary Supplement: Soy protein isolateAdministration Prior to Mastectomy or Lumpectomy. Patients receive oral soy protein isolate twice daily and oral multivitamins once daily. Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. |
| Placebo | Placebo comparator | Other: PlaceboAdministration Prior to Mastectomy or Lumpectomy. Patients receive oral placebo twice daily and oral multivitamins once daily. Treatment continues for 2-4 weeks depending on time from study entry to planned surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not 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 |
|---|---|---|
| Soy protein isolateAlso: isoflavonesArm I: Patients receive oral soy protein isolate twice daily and oral multivitamins once daily. | Dietary supplement | Soy protein isolate |
| PlaceboArm II: Patients receive oral placebo twice daily and oral multivitamins once daily. | Other | Placebo |
Primary outcome
Occurrence of Soy Protein Isolate Effect
Time frame: 1 Year
Determine the effect of soy protein isolate (isoflavones) on modulation of intermediate endpoint biomarkers (such as cell proliferation, apoptosis, and steroid hormones) in women planning to undergo mastectomy or lumpectomy for breast cancer.
1 secondary outcome
Occurrence of Effect on Serum Isoflavone Levels
Time frame: 1 Year
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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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.
Nagi B. Kumar, PhD, RD, FADA study chair
H. Lee Moffitt Cancer Center and Research Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy protein isolate in people with Breast Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 7 sites 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: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: low accrual). Results are not available in the source record.
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?
Occurrence of Soy Protein Isolate Effect (time frame: 1 Year). 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 24 Sep 2012.