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Cancer Vaccine

Turkey Tail Mushroom for Breast Cancer

Phase 2

Recruiting

Led By Larry R. Bergstrom, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Detectable disease as defined by mammography, breast ultrasound of greater than 5mm in size

Not taking aromatase inhibitor or a selective estrogen receptor modifier

Must not have

Current use of any medicinal mushrooms

Other active malignancy 3 years prior to registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well turkey tail mushroom works in treating post-menopausal women with a specific type of breast cancer. Previous evidence suggests that taking turkey tail mushroom can shrink tumors before surgery. Researchers

Who is the study for?

This trial is for post-menopausal women with a specific breast cancer type: HER2-negative and ER-positive. They should be scheduled for surgery to treat their cancer. The eligibility criteria are not fully listed, but typically include factors like general health status and no conflicting conditions.

What is being tested?

The trial is testing the effects of Turkey Tail Mushroom (TTM) extract on shrinking tumors in patients before they undergo surgery. It's based on traditional uses and some evidence suggesting it might help reduce tumor size within two months prior to surgical intervention.

What are the potential side effects?

While the side effects of TTM are not detailed here, common reactions may include digestive discomfort or allergic responses, given its natural origin and use in traditional medicine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer can be seen on scans and is larger than 5mm.

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I am not currently taking any aromatase inhibitors or estrogen blockers.

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I am scheduled for surgery to remove my breast cancer.

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My breast cancer is ER positive, HER2 negative, and newly diagnosed.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using medicinal mushrooms.

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I have not had any other cancer in the last 3 years.

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I am not on any experimental drugs for my cancer.

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I am currently on hormone therapy for cancer.

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I am currently undergoing chemotherapy.

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My cancer is advanced locally or has spread and needs initial treatment.

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I am HIV positive and on antiretroviral therapy.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; at the time of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; at the time of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; at the time of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Ki-67

Secondary study objectives

Adverse effects of Turkey Tail Mushrooms (TTM)

Patient-reported outcomes

Quality of life changes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (TTM)Experimental Treatment2 Interventions

Patients receive TTM PO QD or BID starting at the time of study registration and continuing up to the day prior to SOC surgery (up to 3-6 weeks) in the absence of disease progression or unacceptable toxicity.

0 / 13Eligibility criteria met