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New treatment option for Estrogen Receptor-Positive Breast Carcinoma
Official title Reishi Mushroom Extract for Fatigue and/or Arthralgias/Myalgias in Patients With Breast Cancer on Aromatase Inhibitors
ClinicalTrials.gov ID: NCT06028022
What this study is testing
- What it's testing
- This phase II trial tests how well Reishi mushroom extract works in treating fatigue and/or joint/muscle pain (arthralgias/myalgias) in patients with breast cancer on aromatase inhibitors. Fatigue and arthralgias/myalgias are common symptoms in breast cancer patients taking aromatase inhibitors (AI).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥ 18 years
- History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative
- Fatigue ≥ 4/10
- Currently post-menopausal (as defined by National Comprehensive Cancer Network (version 4.2024), taking any aromatase inhibitor in the curative...
- Prior treatment: last chemotherapy ≥ 90 days prior to randomization (if treated with chemotherapy)
You likely can't join if
- Other known uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome...
- Allergy to mushrooms
- On anticoagulation medication or aspirin or having a known bleeding disorder
- On any specific medication for fatigue (e.g., methylphenidate)
- Metastatic cancer diagnosis (history of nodal metastases is allowed)
- Chronic steroid use, unless on physiologic replacement doses
See the full eligibility criteria
- Age ≥ 18 years
- History of breast cancer, estrogen receptor positive (ER+), Her 2 positive or negative
- Fatigue ≥ 4/10
- Currently post-menopausal (as defined by National Comprehensive Cancer Network (version 4.2024), taking any aromatase inhibitor in the curative setting and planning to be on such for at least 8 weeks after registration...
- Prior treatment: last chemotherapy ≥ 90 days prior to randomization (if treated with chemotherapy)
- On a stable dose of pain medications if pain medications are being regularly used. (i.e., no change in dosage in the past 30 days)
- If on supplements, must be on stable dose with no plan to change; not on or planning any acupuncture or other specific supportive modalities for fatigue or AI arthralgias
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
- White blood cell count (WBC) ≥ 3,000/mm\^3 (obtained ≤ 30 days prior to randomization)
- Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to randomization)
- Platelet count ≥ 100,000/mm\^3 (obtained ≤ 30 days prior to randomization)
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 30 days prior to randomization)
- Alanine aminotransferase (ALT) or aspartate transaminase (AST) ≤ 1.2 x ULN (obtained ≤ 30 days prior to randomization)
- Prothrombin time (PT)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (obtained ≤ 30 days prior to randomization)
- Negative pregnancy test done ≤ 7 days prior to registration, for persons on concurrent ovarian suppression only
- Provide informed consent
- Ability to complete questionnaires
- Willing to return to enrolling institution during the active monitoring phase of the study
- Patients who have had a recent surgery or procedure should be healed and cleared by their clinician and/or surgeon per local standards, prior to registration
- Other known uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune disease, or active/untreated hepatitis
- Allergy to mushrooms
- On anticoagulation medication or aspirin or having a known bleeding disorder
- On any specific medication for fatigue (e.g., methylphenidate)
- Metastatic cancer diagnosis (history of nodal metastases is allowed)
- Chronic steroid use, unless on physiologic replacement doses
- Current use of any medical mushrooms
- On medications for diabetes
- History of symptomatic hypotension
- Taking CYP3A4, CYP2D6 sensitive substrates which can be located at the following link...
- Drugs which exhibit either \>20% inhibition or \>20% induction of CYP2E1 in vivo, such as: Acetaminophen, Dapsone, Enflurane, Halothane, Isoflurane, \& Theophylline
- Taking olaparib
- Any of the following because this study involves an agent that has unknown genotoxic, mutagenic and teratogenic effects:
- Pregnant persons
- Nursing persons
- Persons on concurrent ovarian suppression who are unwilling to employ adequate contraception (e.g., hormonal methods, barrier methods, intrauterine device, abstinence)
- Planned surgery or procedure during time on study and ≤ 14 days after last dose, due to bleeding risks
The study team makes the final eligibility decision.
Where it's taking place
- Albert Lea, Minnesota, United States
- Baxter, Minnesota, United States
- Bemidji, Minnesota, United States
- Brainerd, Minnesota, United States
- Deer River, Minnesota, United States
- Detroit Lakes, Minnesota, United States
- Duluth, Minnesota, United States
- Ely, Minnesota, United States
- Fosston, Minnesota, United States
- Grand Rapids, Minnesota, United States
- Hibbing, Minnesota, United States
- International Falls, Minnesota, United States
- Mankato, Minnesota, United States
- Monticello, Minnesota, United States
- Moose Lake, Minnesota, United States
- Park Rapids, Minnesota, United States
- Princeton, Minnesota, United States
- Rochester, Minnesota, United States
- Sandstone, Minnesota, United States
- Thief River Falls, Minnesota, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Albert Lea, Minnesota, United States; Baxter, Minnesota, United States; Bemidji, Minnesota, United States; Brainerd, Minnesota, United States; Deer River, Minnesota, United States; Detroit Lakes, Minnesota, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.