Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older
• You have a history of breast cancer that is estrogen receptor positive (ER+), and HER2 positive or negative
• You currently rate your fatigue at 4 out of 10 or higher
• You are post-menopausal and currently taking an aromatase inhibitor (a type of hormone-blocking medication) as part of your cancer treatment, and plan to continue it for at least 8 weeks after joining the study (patients also on ovarian suppression medications such as leuprolide or goserelin are welcome, as are those taking CDK 4/6 inhibitors abemaciclib or ribociclib)
• If you had chemotherapy, your last treatment was at least 90 days before joining the study
• If you regularly take pain medications, your dose has not changed in the past 30 days
• If you take supplements, your dose is stable and you have no plans to change it, and you are not currently receiving acupuncture or other specific treatments for fatigue or joint pain related to your medication
• You are generally able to carry out daily activities (your doctor rates your physical functioning as 0, 1, or 2 on a standard scale)
• Your recent blood test results (taken within the last 30 days) show that your white blood cell count, hemoglobin, platelets, liver function, and blood clotting levels are within acceptable ranges (confirm specific values with the trial site)
• If you are on ovarian suppression, you have had a negative pregnancy test within the last 7 days before registering
• You are willing and able to give informed consent and complete questionnaires
• You are able to return to the trial site during the active monitoring period
• If you recently had surgery or a procedure, you have fully healed and been cleared by your doctor or surgeon

Who may not be able to join:

• You have another known, uncontrolled medical condition that causes fatigue, such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, an active infection, an autoimmune disease, or active/untreated hepatitis
• You are allergic to mushrooms
• You take blood-thinning medications (anticoagulants), regular aspirin, or have a known bleeding disorder
• You are currently taking any medication specifically prescribed for fatigue (such as methylphenidate)
• Your cancer has spread to distant parts of your body (metastatic cancer) — though a history of cancer spread only to lymph nodes is allowed
• You regularly use steroid medications, unless it is a low replacement dose prescribed by your doctor
• You are currently using any medicinal mushroom products
• You take medications for diabetes
• You have a history of low blood pressure that causes symptoms
• You take certain medications that interact with specific liver enzymes called CYP3A4 or CYP2D6 (confirm with trial site which medications are included)
• You take certain medications that significantly affect a liver enzyme called CYP2E1, including acetaminophen (paracetamol), dapsone, enflurane, halothane, isoflurane, or theophylline
• You are currently taking olaparib
• You are pregnant or breastfeeding
• You are on ovarian suppression and are unwilling to use adequate contraception during the study
• You have a surgery or procedure planned during the study period or within 14 days after your last dose

Important: Always verify eligibility with the trial site directly before applying.