Estratto di fungo Reishi per affaticamento e/o artralgie/mialgie in pazienti con cancro al seno trattati con inibitori dell'aromatasi
Estratto di fungo Reishi per affaticamento e/o artralgie in pazienti con cancro al seno trattati con inibitori dell'aromatasi: uno studio randomizzato di 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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Clinical Trials Referral Office
- Numero di telefono: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Luoghi di studio
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Minnesota
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Albert Lea, Minnesota, Stati Uniti, 56007
- Attivo, non reclutante
- Mayo Clinic Health System in Albert Lea
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Baxter, Minnesota, Stati Uniti, 56425
- Attivo, non reclutante
- Essentia Health Baxter Clinic
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Bemidji, Minnesota, Stati Uniti, 56601
- Attivo, non reclutante
- Sanford Joe Lueken Cancer Center
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Brainerd, Minnesota, Stati Uniti, 56401
- Attivo, non reclutante
- Essentia Health Saint Joseph's Medical Center
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Deer River, Minnesota, Stati Uniti, 56636
- Attivo, non reclutante
- Essentia Health Deer River Clinic
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Detroit Lakes, Minnesota, Stati Uniti, 56501
- Attivo, non reclutante
- Essentia Health Saint Mary's - Detroit Lakes Clinic
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Duluth, Minnesota, Stati Uniti, 55805
- Attivo, non reclutante
- Essentia Health Cancer Center
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Ely, Minnesota, Stati Uniti, 55731
- Attivo, non reclutante
- Essentia Health Ely Clinic
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Fosston, Minnesota, Stati Uniti, 56542
- Attivo, non reclutante
- Essentia Health Fosston
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Grand Rapids, Minnesota, Stati Uniti, 55744
- Attivo, non reclutante
- Fairview Grand Itasca Clinic & Hospital
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Hibbing, Minnesota, Stati Uniti, 55746
- Attivo, non reclutante
- Essentia Health Hibbing Clinic
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Hibbing, Minnesota, Stati Uniti, 55746
- Attivo, non reclutante
- Fairview Range Medical Center
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International Falls, Minnesota, Stati Uniti, 56649
- Attivo, non reclutante
- Essentia Health International Falls Clinic
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Mankato, Minnesota, Stati Uniti, 56001
- Attivo, non reclutante
- Mayo Clinic Health Systems-Mankato
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Monticello, Minnesota, Stati Uniti, 55362
- Ritirato
- MMCORC CentraCare Monticello Cancer Center
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Moose Lake, Minnesota, Stati Uniti, 55767
- Attivo, non reclutante
- Essentia Health Moose Lake
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Park Rapids, Minnesota, Stati Uniti, 56470
- Attivo, non reclutante
- Essentia Health Park Rapids
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Princeton, Minnesota, Stati Uniti, 55731
- Attivo, non reclutante
- Fairview Northland Medical Center
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Rochester, Minnesota, Stati Uniti, 55905
- Reclutamento
- Mayo Clinic in Rochester
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Investigatore principale:
- Stacy D. D'Andre, M.D.
-
Contatto:
- Clinical Trials Referral Office
- Numero di telefono: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
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Sandstone, Minnesota, Stati Uniti, 55072
- Attivo, non reclutante
- Essentia Health Sandstone
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Thief River Falls, Minnesota, Stati Uniti, 56701
- Attivo, non reclutante
- Sanford Thief River Falls Medical Center
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Virginia, Minnesota, Stati Uniti, 55792
- Attivo, non reclutante
- Essentia Health Virginia Clinic
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Worthington, Minnesota, Stati Uniti, 56187
- Attivo, non reclutante
- Sanford Worthington Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
Ancillary studies Given PO Given Reishi mushroom extract PO
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Ancillary studies Given PO Given Reishi mushroom extract PO
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in fatigue scores
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in quality of life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Stacy D. D'Andre, MD, Mayo Clinic in Rochester
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- MC221002
- MC221002 (Altro identificatore: Mayo Clinic in Rochester)
- NCI-2023-06578 (Identificatore di registro: CTRP (Clinical Trials Reporting Program))
- 23-005266 (Altro identificatore: Mayo Clinic Institutional Review Board)
- MNCCTN032 (Altro identificatore: Minnesota Cancer Clinical Trials Network)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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