Breast CancerPhase 1NCT00709020
White Button Mushroom Extract in Preventing the Recurrence of Breast Cancer in Postmenopausal Breast Cancer Survivors
A Phase 1 study testing white button mushroom extract, flow cytometry and high performance liquid chromatography in people with Breast Cancer and Cancer Survivor, run by City of Hope Medical Center at 2 sites in United States.
Trial summary
RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors. PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivor
- What is being tested?
- white button mushroom extract, flow cytometry and high performance liquid chromatography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2008to Dec 2010
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Prior diagnosis of infiltrating carcinoma of the breast ≥ 5 years prior to study entry
- Prior diagnosis of ductal carcinoma in situ
- No evidence of disease
- Completed all cancer therapy, with the exception of reconstructive surgery, at least 6 months prior to study entry
- Meets one of the following criteria:
- Normal mammogram within 1 year of study entry
- Underwent bilateral mastectomy and has been in remission for 5 years, as documented by an oncologist
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,500/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Postmenopausal, defined as any of the following:
- Continuous absence of menstruation for 12+ months
- Status post bilateral oophorectomy
- Status post hysterectomy with follicle-stimulating hormone in menopausal range
- Creatinine ≤ 1.5 times upper limit of normal (ULN) or less
- Total bilirubin ≤ 1.5 times ULN
- AST and ALT < 2 times ULN
- No allergy to mushrooms
- No personal history of any invasive cancer, other than breast cancer, or squamous cell or basal cell skin cancer
- No osteoporosis, defined as a bone-mineral density T-score of < -2.5 on dual-energy x-ray absorptiometry scan
- No major systemic infections or other major medical illnesses of the cardiovascular, respiratory, or digestive system
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior and no concurrent hormone-modifying medications, including any of the following:
- Oral contraceptives
- Hormone replacement
- Selective estrogen receptor modifiers
- Other aromatase inhibitors
- Gonadotropic-releasing hormone modifiers
- At least 1 month since prior and no other concurrent mushroom extracts or DHEA as a dietary supplement
- No concurrent therapy, except continued medications for unrelated illness that are not excluded, and necessary medications for unrelated acute illnesses that may occur during the study (e.g., cold, flu, or infection)
- No more than 3 concurrent servings per week of the following foods:
- Flaxseeds and flaxseed meal
- High-energy bars or diet bars containing soy or soy protein
- Liquid-nutrition drinks containing soy or soy protein (e.g., Odwalla Future Shake or Ensure Plus)
- Miso soup
- Natto
- Packaged mixed dishes with soy or tofu (e.g., lasagna, burritos, or stir-fry)
- Cooked soybeans or edamame (i.e., green soybeans)
- Roasted soy nuts
- Soymilk, regular or low-fat, plain or flavored
- Soy cheese, such as cheddar, mozzarella, cram cheese, or parmesan (includes all foods made with soy cheese)
- Soy protein powders (e.g., performance or body-builder powders)
- Soy yogurt, all types
- Soy sauce, tamari, teriyaki sauce, Szechuan sauce, or hoisin sauce
- Soy ice cream, tofutti, or other soy desserts
- Tempeh, all types
- Tofu, all types, including low-fat, flavored, marinated, and smoked
- Tofu or soy breakfast sausage, bacon, or other breakfast meat
- Tofu or soy cold cuts, hot dogs, or other deli meat substitutes
- Veggie soy or tofu burger, ground meat substitute (texturized vegetable protein), or soy or tofu, chicken, or turkey
- Concurrent supplemental calcium and/or vitamin D and bisphosphonates allowed provided doses remain constant throughout the run-in and treatment portions of the trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
City of Hope Medical Group
Pasadena, California, 91105
About this study
Official title: A Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors
RATIONALE: White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors.
PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.
Read the detailed description
OBJECTIVES:
Primary
- To show that a whole food extract of white button mushrooms (WBM) can inhibit aromatase-induced estrogen biosynthesis in postmenopausal women who are breast cancer survivors (BCS).
- To determine the optimal daily dose of WBM needed to induce aromatase inhibition of estrogen biosynthesis in these patients.
- To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to moderate the anticancer effects of WBM.
Secondary
- To determine the safety and tolerability of WBM in humans via serial comprehensive symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre- and post-treatment comprehensive lipid panels.
- To explore potential alternate antitumor mechanisms, specifically the effect of WBM on cytokines as well as innate and adaptive cellular immunity.
- To describe barriers experienced in recruitment of ethnically diverse subjects from the community into a secondary prevention BCS trial utilizing a dietary supplement intervention in an effort to enhance feasibility of a subsequent phase II trial.
OUTLINE: This is a dose-escalation study.
Patients receive oral white button mushroom extract twice daily for 12 weeks in the absence of a second primary ductal carcinoma in situ, invasive breast cancer, or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during treatment for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Blood and urine samples are analyzed for concentrations of C-18 unsaturated fatty acids (CUFA) by high-performance liquid chromatography tandem-mass spectrometry. Blood samples are also analyzed for anti-aromatase activity by ex vivo plasma aromatase inhibition assays; circulating sex steroid hormones by radioimmunoassay; serum immune cytokine levels by multiplex cytokine analyses; immunophenotyping, NK-cell activation status, and NK-cell function by multiparameter flow cytometry; lipid levels by lipid assays; and biochemical markers of bone metabolism by bone metabolism marker assays. DNA, RNA, and plasma samples are stored for post-trial pharmacogenomic studies.
- Conditions
- Breast Cancer, Cancer Survivor
- Being tested
- white button mushroom extract, flow cytometry, high performance liquid chromatography, laboratory biomarker analysis, mass spectrometry
- Keywords
- cancer survivor, 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.
white button mushroom extractDrug
Dose escalation with six evaluable subjects per dose level. Doses begin at 5 g/day, then 8 g/day, then 10 g/day then 13 g/day.
flow cytometryOther
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
high performance liquid chromatographyOther
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
laboratory biomarker analysisOther
Performed on blood samples taken pre-treatment on day 1 and on day 85 after treatment.
mass spectrometryOther
Performed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment.
pharmacogenomic studiesOther
Performed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment.
Performed on blood samples taken pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
| Study group | Role | What they receive |
|---|---|---|
| White Button Mushroom Extract | Experimental | Not described Receives: Drug: white button mushroom extract; Other: flow cytometry; Other: high performance liquid chromatography; Other: laboratory biomarker analysis; Other: mass spectrometry; Other: pharmacogenomic studies; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2)
Measured: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
Serum sex steroid hormone levels
Measured: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
Optimal daily dose of WBM
Measured: 1 year after completion of the study
Pharmacokinetics of C-18 unsaturated fatty acids (CUFA) as measured by high-performance liquid chromatography tandem-mass spectrometry
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
Pharmacodynamics of WBM as measured by ex vivo plasma aromatase inhibition assays
Measured: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
Secondary outcomes (7)
Safety and tolerability of WBM as assessed by NCI CTCAE v3.0, symptom logs, bone metabolism markers, and pre- and post-treatment comprehensive lipid panels
Measured: 4 months after completion of treatment
Effect of WBM on cytokines as measured by multiplex cytokine analyses
Measured: Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.
Effect of WBM on innate and adaptive cellular immunity as measured by immunologic assays
Measured: Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.
Barriers to recruitment of ethnically diverse patients from the community
Measured: 4 months after completion of treatment
Dietary sources of CUFA as measured by food frequency questionnaires
Measured: Day -14 before treatment begins, day 1, 29, 57 and 85 after treatment begins
Bone metabolism markers (i.e., serum procollagen type-1 propeptide and urine N-telopeptide crosslinks)
Measured: Day 1 of treatment and day 85 of treatment
Fasting lipids (i.e., total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)
Measured: Day 1 of treatment and day 85 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2010
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- Investigators
- Shiuan Chen, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709020
- Sponsor's protocol ID
- 07213
- Other IDs
- P30CA033572, CHNMC-07213, CDR0000599204
- Status last verified
- Jun 2015
- First submitted
- 2 Jul 2008
- 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 Translational Breast Cancer Prevention Trial of Mushroom Powder in Postmenopausal Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00709020
- Acronym / sponsor ID
- 07213
- Conditions
- Breast Cancer, Cancer Survivor
- Keywords
- cancer survivor, breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jul 2008 (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: White button mushroom extract may stop or delay the recurrence of breast cancer in postmenopausal breast cancer survivors.
PURPOSE: This phase I trial is studying the side effects and best dose of white button mushroom extract in preventing the recurrence of breast cancer in postmenopausal women who are breast cancer survivors.
Detailed description
OBJECTIVES:
Primary
- To show that a whole food extract of white button mushrooms (WBM) can inhibit aromatase-induced estrogen biosynthesis in postmenopausal women who are breast cancer survivors (BCS).
- To determine the optimal daily dose of WBM needed to induce aromatase inhibition of estrogen biosynthesis in these patients.
- To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to moderate the anticancer effects of WBM.
Secondary
- To determine the safety and tolerability of WBM in humans via serial comprehensive symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre- and post-treatment comprehensive lipid panels.
- To explore potential alternate antitumor mechanisms, specifically the effect of WBM on cytokines as well as innate and adaptive cellular immunity.
- To describe barriers experienced in recruitment of ethnically diverse subjects from the community into a secondary prevention BCS trial utilizing a dietary supplement intervention in an effort to enhance feasibility of a subsequent phase II trial.
OUTLINE: This is a dose-escalation study.
Patients receive oral white button mushroom extract twice daily for 12 weeks in the absence of a second primary ductal carcinoma in situ, invasive breast cancer, or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during treatment for pharmacokinetic, pharmacodynamic, and immunologic correlative studies. Blood and urine samples are analyzed for concentrations of C-18 unsaturated fatty acids (CUFA) by high-performance liquid chromatography tandem-mass spectrometry. Blood samples are also analyzed for anti-aromatase activity by ex vivo plasma aromatase inhibition assays; circulating sex steroid hormones by radioimmunoassay; serum immune cytokine levels by multiplex cytokine analyses; immunophenotyping, NK-cell activation status, and NK-cell function by multiparameter flow cytometry; lipid levels by lipid assays; and biochemical markers of bone metabolism by bone metabolism marker assays. DNA, RNA, and plasma samples are stored for post-trial pharmacogenomic studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| White Button Mushroom Extract | Experimental | Drug: white button mushroom extract, Other: flow cytometry, Other: high performance liquid chromatography, Other: laboratory biomarker analysis, Other: mass spectrometry, Other: pharmacogenomic studies, Other: pharmacological study |
Who may qualify
- Ages
- 21 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 |
|---|---|---|
| white button mushroom extractDose escalation with six evaluable subjects per dose level. Doses begin at 5 g/day, then 8 g/day, then 10 g/day then 13 g/day. | Drug | White Button Mushroom Extract |
| flow cytometryPerformed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment. | Other | White Button Mushroom Extract |
| high performance liquid chromatographyPerformed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment. | Other | White Button Mushroom Extract |
| laboratory biomarker analysisPerformed on blood samples taken pre-treatment on day 1 and on day 85 after treatment. | Other | White Button Mushroom Extract |
| mass spectrometryPerformed on blood samples taken day -14 and -7 prior to treatment and days 1, 8, 15, 29, 57 and 85 of treatment. | Other | White Button Mushroom Extract |
| pharmacogenomic studiesPerformed on blood samples taken on days 1, 8, 15, 29, 57 and 85 of treatment. | Other | White Button Mushroom Extract |
| pharmacological studyPerformed on blood samples taken pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment. | Other | White Button Mushroom Extract |
Primary outcome
Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2)
Time frame: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
Serum sex steroid hormone levels
Time frame: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.
Optimal daily dose of WBM
Time frame: 1 year after completion of the study
Pharmacokinetics of C-18 unsaturated fatty acids (CUFA) as measured by high-performance liquid chromatography tandem-mass spectrometry
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
Pharmacodynamics of WBM as measured by ex vivo plasma aromatase inhibition assays
Time frame: Pre-dose and at 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours after White Button Mushroon extract on day 1 of treatment and pre-dose on days 8, 15, 29, 57 and 85 after start of treatment.
7 secondary outcomes
Safety and tolerability of WBM as assessed by NCI CTCAE v3.0, symptom logs, bone metabolism markers, and pre- and post-treatment comprehensive lipid panels
Time frame: 4 months after completion of treatment
Effect of WBM on cytokines as measured by multiplex cytokine analyses
Time frame: Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.
Effect of WBM on innate and adaptive cellular immunity as measured by immunologic assays
Time frame: Day -14 and Day -7 before first treatment, Day 1, 8, 15, 29, 57 and 85 after treatment begins.
Barriers to recruitment of ethnically diverse patients from the community
Time frame: 4 months after completion of treatment
Dietary sources of CUFA as measured by food frequency questionnaires
Time frame: Day -14 before treatment begins, day 1, 29, 57 and 85 after treatment begins
Bone metabolism markers (i.e., serum procollagen type-1 propeptide and urine N-telopeptide crosslinks)
Time frame: Day 1 of treatment and day 85 of treatment
Fasting lipids (i.e., total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides)
Time frame: Day 1 of treatment and day 85 of treatment
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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Shiuan Chen, PhD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing white button mushroom extract, flow cytometry and high performance liquid chromatography in people with Breast Cancer and Cancer Survivor, run by City of Hope Medical Center at 2 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: 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 2 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. 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?
Efficacy of white button mushroom extract (WBM) in reducing serum estradiol (E2) (time frame: Baseline prior to treatment, days 8, 15, 29, 57 and 85 after the start of treatment.). The study lists 5 primary outcomes in all. 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.