Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 80
- 试验地点
- 45
- 主要终点
- Change in fatigue scores
研究概览
简要总结
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). Given the long duration of AI treatment for some women (up to 10 years), these symptoms can significantly impact quality of life and premature discontinuation of AIs, a beneficial medication. Reishi mushrooms are among several medicinal mushrooms that have been used for hundreds of years, mainly in Asian countries, to help enhance the immune system, reduce stress, improve sleep, and lessen fatigue. Reishi mushroom extracts have not been studied explicitly for treatment-induced arthralgias/myalgias, but have been shown to improve quality of life, muscular strength, pain, and flexibility. Information from this study may help researchers determine the effect of Reishi mushroom extract on fatigue and arthralgias/myalgias in breast cancer patients receiving an AI.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of 1,000 mg three times daily (TID) of Reishi mushroom extracts as therapy for cancer-related fatigue measured by uniscale measurement at the end of four weeks.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of Reishi mushroom extracts as therapy for cancer-related arthralgias at the end of four weeks and four weeks after cross-over as measured by the Brief Pain index (BPI)-adapted for AI associated arthralgias.
II. To evaluate the effect of Reishi mushroom extracts on cancer-related quality of life (QOL), as measured by uniscale, at the end of four weeks and four weeks after cross-over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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. [Patients on concurrent ovarian suppression (such as with leuprolide acetate, goserelin) are allowed]; CDK 4/6 inhibitors abemaciclib, ribociclib ARE allowed
- •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
排除标准
- •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:
- •https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems
- •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
研究组 & 干预措施
Arm I (Reishi mushroom extract, placebo)
Patients receive Reishi mushroom extract PO TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Mushroom Extract (Dietary Supplement)
Arm I (Reishi mushroom extract, placebo)
Patients receive Reishi mushroom extract PO TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo Administration (Drug)
Arm I (Reishi mushroom extract, placebo)
Patients receive Reishi mushroom extract PO TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm I (Reishi mushroom extract, placebo)
Patients receive Reishi mushroom extract PO TID on days 1-28 for weeks 1-4 and then placebo PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm II (placebo, Reishi mushroom extract)
Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Mushroom Extract (Dietary Supplement)
Arm II (placebo, Reishi mushroom extract)
Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm II (placebo, Reishi mushroom extract)
Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo Administration (Drug)
Arm II (placebo, Reishi mushroom extract)
Patients receive placebo PO TID on days 1-28 for weeks 1-4 and Reishi mushroom extract PO TID on days 1-28 for weeks 5-8 in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Change in fatigue scores
时间窗: Baseline to end of four weeks
Based on a single item fatigue uniscale question. Will be compared between arms using a two-sided two-sample t-test assuming equal variances in each group.
次要结局
- Change in quality of life(Baseline to the end of four weeks and four weeks after cross-over)
- Incidence of adverse events(Up to 30 days follow-up)
- Change in arthralgias(Baseline to the end of four weeks and four weeks after cross-over)