Extrato de cogumelo Reishi para fadiga e/ou artralgias/mialgias em pacientes com câncer de mama em uso de inibidores de aromatase
Extrato de cogumelo Reishi para fadiga e/ou artralgias em pacientes com câncer de mama em uso de inibidores de aromatase: um ensaio randomizado de fase II MNCCTN
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.
Visão geral do estudo
Status
Descrição detalhada
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.
III. To evaluate the efficacy of Reishi mushroom extracts on mood, as assessed by the World Health Organization Five Well-Being Index (WHO-5) item well-being scale, at the end of four weeks and four weeks after cross-over.
IV. To evaluate treatment toxicity between the two treatment arms, as measured by a patient symptom experience diary and weekly calls from the study team.
V. To evaluate the interest, knowledge, and acceptance of integrative treatments for cancer-related symptoms.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive Reishi mushroom extract orally (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.
ARM II: 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.
After completion of study treatment, patients are followed up at 30 days.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Clinical Trials Referral Office
- Número de telefone: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
Locais de estudo
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Minnesota
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Albert Lea, Minnesota, Estados Unidos, 56007
- Ativo, não recrutando
- Mayo Clinic Health System in Albert Lea
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Baxter, Minnesota, Estados Unidos, 56425
- Ativo, não recrutando
- Essentia Health Baxter Clinic
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Bemidji, Minnesota, Estados Unidos, 56601
- Ativo, não recrutando
- Sanford Joe Lueken Cancer Center
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Brainerd, Minnesota, Estados Unidos, 56401
- Ativo, não recrutando
- Essentia Health Saint Joseph's Medical Center
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Deer River, Minnesota, Estados Unidos, 56636
- Ativo, não recrutando
- Essentia Health Deer River Clinic
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Detroit Lakes, Minnesota, Estados Unidos, 56501
- Ativo, não recrutando
- Essentia Health Saint Mary's - Detroit Lakes Clinic
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Duluth, Minnesota, Estados Unidos, 55805
- Ativo, não recrutando
- Essentia Health Cancer Center
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Ely, Minnesota, Estados Unidos, 55731
- Ativo, não recrutando
- Essentia Health Ely Clinic
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Fosston, Minnesota, Estados Unidos, 56542
- Ativo, não recrutando
- Essentia Health Fosston
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Grand Rapids, Minnesota, Estados Unidos, 55744
- Ativo, não recrutando
- Fairview Grand Itasca Clinic & Hospital
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Hibbing, Minnesota, Estados Unidos, 55746
- Ativo, não recrutando
- Essentia Health Hibbing Clinic
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Hibbing, Minnesota, Estados Unidos, 55746
- Ativo, não recrutando
- Fairview Range Medical Center
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International Falls, Minnesota, Estados Unidos, 56649
- Ativo, não recrutando
- Essentia Health International Falls Clinic
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Mankato, Minnesota, Estados Unidos, 56001
- Ativo, não recrutando
- Mayo Clinic Health Systems-Mankato
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Monticello, Minnesota, Estados Unidos, 55362
- Retirado
- MMCORC CentraCare Monticello Cancer Center
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Moose Lake, Minnesota, Estados Unidos, 55767
- Ativo, não recrutando
- Essentia Health Moose Lake
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Park Rapids, Minnesota, Estados Unidos, 56470
- Ativo, não recrutando
- Essentia Health Park Rapids
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Princeton, Minnesota, Estados Unidos, 55731
- Ativo, não recrutando
- Fairview Northland Medical Center
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Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- Mayo Clinic in Rochester
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Investigador principal:
- Stacy D. D'Andre, M.D.
-
Contato:
- Clinical Trials Referral Office
- Número de telefone: 855-776-0015
- E-mail: mayocliniccancerstudies@mayo.edu
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Sandstone, Minnesota, Estados Unidos, 55072
- Ativo, não recrutando
- Essentia Health Sandstone
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Thief River Falls, Minnesota, Estados Unidos, 56701
- Ativo, não recrutando
- Sanford Thief River Falls Medical Center
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Virginia, Minnesota, Estados Unidos, 55792
- Ativo, não recrutando
- Essentia Health Virginia Clinic
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Worthington, Minnesota, Estados Unidos, 56187
- Ativo, não recrutando
- Sanford Worthington Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion 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. [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
Exclusion Criteria:
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Other known uncontrolled medical conditions causing fatigue such as untreated thyroid disease, depression, fibromyalgia, chronic fatigue syndrome, infection, autoimmune disease, or active/untreated hepatitis
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Allergy to mushrooms
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On anticoagulation medication or aspirin or having a known bleeding disorder
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On any specific medication for fatigue (e.g., methylphenidate)
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Metastatic cancer diagnosis (history of nodal metastases is allowed)
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Chronic steroid use, unless on physiologic replacement doses
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Current use of any medical mushrooms
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On medications for diabetes
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History of symptomatic hypotension
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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
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Drugs which exhibit either >20% inhibition or >20% induction of CYP2E1 in vivo, such as: Acetaminophen, Dapsone, Enflurane, Halothane, Isoflurane, & Theophylline
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Taking olaparib
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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)
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Planned surgery or procedure during time on study and ≤ 14 days after last dose, due to bleeding risks
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
Ancillary studies
Outros nomes:
Ancillary studies Given PO Given Reishi mushroom extract PO
Outros nomes:
|
|
Experimental: 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. |
Ancillary studies
Outros nomes:
Ancillary studies Given PO Given Reishi mushroom extract PO
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in fatigue scores
Prazo: 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. |
Baseline to end of four weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in quality of life
Prazo: Baseline to the end of four weeks and four weeks after cross-over
|
Measured by the World Health Organization-Five Well-Being Index. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach. |
Baseline to the end of four weeks and four weeks after cross-over
|
|
Change in arthralgias
Prazo: Baseline to the end of four weeks and four weeks after cross-over
|
Measured by the Brief Pain Inventory for Aromatase Inhibitor Induced Arthralgia. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach. |
Baseline to the end of four weeks and four weeks after cross-over
|
|
Incidence of adverse events
Prazo: Up to 30 days follow-up
|
Measured by the symptom experience diary. Will be compared between arms using two-sample, two-sided t-tests assuming equal variances and alpha levels of 5%. The analyses of the crossover portion of the study will be descriptive. Mean values will be plotted over time by arm. A formal crossover analysis will also be performed using Senn's linear modeling approach. |
Up to 30 days follow-up
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stacy D. D'Andre, MD, Mayo Clinic in Rochester
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- MC221002
- MC221002 (Outro identificador: Mayo Clinic in Rochester)
- NCI-2023-06578 (Identificador de registro: CTRP (Clinical Trials Reporting Program))
- 23-005266 (Outro identificador: Mayo Clinic Institutional Review Board)
- MNCCTN032 (Outro identificador: Minnesota Cancer Clinical Trials Network)
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