Study on Turkey Tail Mushroom for Post-Menopausal Women with HER2-Negative ER-Positive Breast Cancer Undergoing Surgery

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06450873

Provider View

This clinical trial is exploring the use of turkey tail mushroom (TTM) to see if it can help treat post-menopausal women with HER2-negative, ER-positive breast cancer who are having surgery. TTM is a common mushroom used in traditional medicine, and previous studies suggest it may help shrink tumors before surgery.

Patient Parameters

Program Overview

The purpose of this phase II study is to find out if turkey tail mushroom (TTM) can effectively treat post-menopausal women with HER2-negative, estrogen receptor (ER)-positive breast cancer who are scheduled for surgery. TTM is a common mushroom used in traditional Chinese medicine for various health benefits, including cancer treatment. Previous evidence suggests that TTM may help shrink tumors in the time between diagnosis and surgery. This study aims to determine if TTM can be a beneficial treatment option for these patients.

Description

The main goal of this study is to see if taking turkey tail mushroom (TTM) can change the growth rate of breast cancer cells in women with HER2-negative, ER-positive breast cancer. Researchers will also look at any side effects from taking TTM and see if it affects quality of life, mood, and energy levels.

Participants will take TTM by mouth once or twice a day from the time they join the study until the day before their scheduled surgery, which could be up to 3-6 weeks. They will continue taking TTM unless their disease progresses or they experience unacceptable side effects.

After finishing the study treatment, participants will have a follow-up visit 7-30 days after their last dose to check on their health and any effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older
  • Diagnosed with HER2-negative, ER-positive breast cancer, with tissue available for specific testing
  • Scheduled for breast surgery
  • Detectable cancer larger than 5mm on a mammogram or ultrasound
  • Post-menopausal, defined by:
    • No menstrual period for over 12 months, or
    • Removal of both ovaries, or
    • Specific hormone levels
  • Not taking certain breast cancer medications
  • In good general health with a performance status of 0, 1, or 2
  • Adequate blood counts and organ function based on recent tests
  • Able to provide written consent and complete a symptom diary

Exclusion Criteria

  • Currently using any medicinal mushrooms
  • Have advanced cancer needing additional therapy or cancer that has spread
  • Currently receiving chemotherapy
  • Taking certain breast cancer medications
  • Allergic to mushrooms
  • Have serious health conditions that could interfere with the study
  • Have a weakened immune system
  • HIV positive and on antiretroviral therapy
  • Have uncontrolled illnesses like infections or heart problems
  • Participating in another cancer treatment study
  • Have had another active cancer in the past 3 years, except for certain skin or cervical cancers

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Arizona85259ScottsdaleArizona

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