Breast CancerPhase 1NCT00680667
Clinical Trial of Trametes Versicolor in Women With Breast Cancer
A Phase 1 study testing Coriolus versicolor extract in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 2 sites in United States.
Trial summary
RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer. PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor extract in treating women with stage I, stage II, or stage III breast cancer who have… Read more about this study
- Who is it for?
- Ages 21 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Coriolus versicolor extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Apr 2011
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
- Estrogen and/or progesterone receptor-negative or positive
- Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
- Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
- Adequate organ function within 14 days of study enrollment including the following:
- Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
Show all 11Show fewer
- Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN
- Renal: Creatinine ≤ 20% times ULN
- Nutritional status: Albumin ≥ 3.0 g/dL
- Negative pregnancy test
- Voluntary written consent before performance of any study-related procedure not part of the normal medical care
Who cannot join
- Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor.
- Known allergy to fungi, including mushrooms
- Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
- Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks
- Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
- Unwilling to discontinue excluded medications and supplements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bastyr University
Kenmore, Washington
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer
RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor extract in treating women with stage I, stage II, or stage III breast cancer who have finished radiation therapy.
Read the detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of oral coriolus versicolor extract in women with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive (as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently completed standard post-surgery radiotherapy.
Secondary
- To determine the feasibility of measuring changes in fatigue and quality of life of patients treated with this drug.
- To characterize the toxicity of this drug in these patients.
- To gather preliminary data that compare baseline and post-treatment immunologic measures, including differential blood counts (i.e., WBC), natural killer cell activity, phagocytic index, regulatory cell assay, T/B/NK cell population subset assays, peripheral blood mononuclear cell production of levels of interferon gamma, and tumor necrosis factor-alpha in these patients.
OUTLINE: Patients receive oral coriolus versicolor extract twice daily for 6 weeks.
Patients undergo quality of life and fatigue assessment at baseline, weekly during study, and at the 3-week follow-up visit.
Blood samples are collected periodically for immunological marker studies. Samples are analyzed for T-regulatory cell, T-and B-lymphocyte, and NK cell activity in peripheral blood mononuclear cells (PBMC), phagocytic index in monocytes and granulocytes, and cytokine secretion and upregulation by flow cytometry, cytotoxicity assays, cytolysis assays, T-regulatory cell assay, or T/B/NK cell population subset assays. Changes in the production of tumor necrosis factor-alpha and interferon-gamma in serum and in supernatants of PBMCs are analyzed via standard enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed at 3 weeks.
- Conditions
- Breast Cancer
- Being tested
- Coriolus versicolor extract
- Keywords
- ductal breast carcinoma, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coriolus versicolor extractBiological
Also called T. versicolor, Tv, turkey tail
Trametes versicolor (Tv) capsules at the assigned dose level (3 grams/day up to 24 grams/day) twice a day every day and continuing for weeks.
| Study group | Role | What they receive |
|---|---|---|
| Trametes Versicolor | Experimental | Females with Stage I-III infiltrating ductal adenocarcinoma of the breast being treated with Trametes versicolor capsules for 6 weeks after receiving radiation therapy. Receives: Biological: Coriolus versicolor extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: Up to 6 Weeks After Treatment
Secondary outcomes (5)
Quality of life
as measured by the Functional Assessment of Cancer Therapy-for Patients With Breast, v4.0, questionnaire. The FACT-B is a 37-item quesionnaire using a 5-point Likert scale that evaluates physical well-being, social/family well-being, emotional well-being, functional well-being and additional concerns of breast cancer patients.
Measured: Over 6 Weeks
Fatigue
as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue, v4.0, questionnaire. The FACIT-Fatigue is a 13 item fatigue scale collected at baseline, weekly and 6 weeks, and at the 3 week follow-up visit.
Measured: Over 6 Weeks
Symptom Assessment
Toxicity will be assessed by the NCI CTCAE v3.0 (see Adverse Event section). The Symptom Assessment questionnaire is completed weekly during study and once at the 3-week follow-up visit
Measured: Weekly and at 3 Week Follow-Up
NK cell activity
Percent change in NK cell activity associated with coriolus versicolor extract
Measured: Over 6 weeks
comparison of immunologic measures
Will be performed by collecting peripheral blood at baseline, weeks 2,4,6 and 9 during study.
Preliminary data that compare baseline and post-treatment immunologic measures including natural killer cell activity, phagocytic index, T regulatory cell assay, T/B/NK cell population subset assays, and cytokine levels.
Measured: Baseline and Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startApr 2007
- Primary completionApr 2011
- Study completionApr 2011
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 Masonic Cancer Center, University of MinnesotaThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Carolyn Torkelson, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680667
- Sponsor's protocol ID
- 2007LS019
- Other IDs
- U19AT001998, UMN-0611M96168
- Status last verified
- Nov 2017
- First submitted
- 18 May 2008
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT00680667
- Acronym / sponsor ID
- 2007LS019
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Apr 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 20 May 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: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor extract in treating women with stage I, stage II, or stage III breast cancer who have finished radiation therapy.
Detailed description
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of oral coriolus versicolor extract in women with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive (as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently completed standard post-surgery radiotherapy.
Secondary
- To determine the feasibility of measuring changes in fatigue and quality of life of patients treated with this drug.
- To characterize the toxicity of this drug in these patients.
- To gather preliminary data that compare baseline and post-treatment immunologic measures, including differential blood counts (i.e., WBC), natural killer cell activity, phagocytic index, regulatory cell assay, T/B/NK cell population subset assays, peripheral blood mononuclear cell production of levels of interferon gamma, and tumor necrosis factor-alpha in these patients.
OUTLINE: Patients receive oral coriolus versicolor extract twice daily for 6 weeks.
Patients undergo quality of life and fatigue assessment at baseline, weekly during study, and at the 3-week follow-up visit.
Blood samples are collected periodically for immunological marker studies. Samples are analyzed for T-regulatory cell, T-and B-lymphocyte, and NK cell activity in peripheral blood mononuclear cells (PBMC), phagocytic index in monocytes and granulocytes, and cytokine secretion and upregulation by flow cytometry, cytotoxicity assays, cytolysis assays, T-regulatory cell assay, or T/B/NK cell population subset assays. Changes in the production of tumor necrosis factor-alpha and interferon-gamma in serum and in supernatants of PBMCs are analyzed via standard enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed at 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trametes Versicolor | Experimental | Biological: Coriolus versicolor extractFemales with Stage I-III infiltrating ductal adenocarcinoma of the breast being treated with Trametes versicolor capsules for 6 weeks after receiving radiation therapy. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
- Estrogen and/or progesterone receptor-negative or positive
- Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
- Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
- Adequate organ function within 14 days of study enrollment including the following:
Key exclusion criteria (6 listed)
- Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor.
- Known allergy to fungi, including mushrooms
- Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
- Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks
- Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
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 |
|---|---|---|
| Coriolus versicolor extractAlso: T. versicolor, Tv, turkey tailTrametes versicolor (Tv) capsules at the assigned dose level (3 grams/day up to 24 grams/day) twice a day every day and continuing for weeks. | Biological | Trametes Versicolor |
Primary outcome
Maximum tolerated dose
Time frame: Up to 6 Weeks After Treatment
5 secondary outcomes
Quality of life
Time frame: Over 6 Weeks
Fatigue
Time frame: Over 6 Weeks
Symptom Assessment
Time frame: Weekly and at 3 Week Follow-Up
NK cell activity
Time frame: Over 6 weeks
comparison of immunologic measures
Time frame: Baseline and Post-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 29 Nov 2017.
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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.
Carolyn Torkelson, MD principal investigator
Masonic Cancer Center, University of Minnesota
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 Coriolus versicolor extract in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota 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?
The sponsor lists 11 inclusion and 6 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 29 Nov 2017. 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?
Maximum tolerated dose (time frame: Up to 6 Weeks After Treatment). 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 29 Nov 2017.