아로마타제 억제제를 사용하는 유방암 환자의 피로 및/또는 관절통/근육통을 위한 영지버섯 추출물
아로마타제 억제제를 사용하는 유방암 환자의 피로 및/또는 관절통을 위한 영지버섯 추출물: 무작위 2상 MNCCTN 시험
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Clinical Trials Referral Office
- 전화번호: 855-776-0015
- 이메일: mayocliniccancerstudies@mayo.edu
연구 장소
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Minnesota
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Albert Lea, Minnesota, 미국, 56007
- 모집하지 않고 적극적으로
- Mayo Clinic Health System in Albert Lea
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Baxter, Minnesota, 미국, 56425
- 모집하지 않고 적극적으로
- Essentia Health Baxter Clinic
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Bemidji, Minnesota, 미국, 56601
- 모집하지 않고 적극적으로
- Sanford Joe Lueken Cancer Center
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Brainerd, Minnesota, 미국, 56401
- 모집하지 않고 적극적으로
- Essentia Health Saint Joseph's Medical Center
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Deer River, Minnesota, 미국, 56636
- 모집하지 않고 적극적으로
- Essentia Health Deer River Clinic
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Detroit Lakes, Minnesota, 미국, 56501
- 모집하지 않고 적극적으로
- Essentia Health Saint Mary's - Detroit Lakes Clinic
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Duluth, Minnesota, 미국, 55805
- 모집하지 않고 적극적으로
- Essentia Health Cancer Center
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Ely, Minnesota, 미국, 55731
- 모집하지 않고 적극적으로
- Essentia Health Ely Clinic
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Fosston, Minnesota, 미국, 56542
- 모집하지 않고 적극적으로
- Essentia Health Fosston
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Grand Rapids, Minnesota, 미국, 55744
- 모집하지 않고 적극적으로
- Fairview Grand Itasca Clinic & Hospital
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Hibbing, Minnesota, 미국, 55746
- 모집하지 않고 적극적으로
- Essentia Health Hibbing Clinic
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Hibbing, Minnesota, 미국, 55746
- 모집하지 않고 적극적으로
- Fairview Range Medical Center
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International Falls, Minnesota, 미국, 56649
- 모집하지 않고 적극적으로
- Essentia Health International Falls Clinic
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Mankato, Minnesota, 미국, 56001
- 모집하지 않고 적극적으로
- Mayo Clinic Health Systems-Mankato
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Monticello, Minnesota, 미국, 55362
- 빼는
- MMCORC CentraCare Monticello Cancer Center
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Moose Lake, Minnesota, 미국, 55767
- 모집하지 않고 적극적으로
- Essentia Health Moose Lake
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Park Rapids, Minnesota, 미국, 56470
- 모집하지 않고 적극적으로
- Essentia Health Park Rapids
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Princeton, Minnesota, 미국, 55731
- 모집하지 않고 적극적으로
- Fairview Northland Medical Center
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Rochester, Minnesota, 미국, 55905
- 모병
- Mayo Clinic in Rochester
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수석 연구원:
- Stacy D. D'Andre, M.D.
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연락하다:
- Clinical Trials Referral Office
- 전화번호: 855-776-0015
- 이메일: mayocliniccancerstudies@mayo.edu
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Sandstone, Minnesota, 미국, 55072
- 모집하지 않고 적극적으로
- Essentia Health Sandstone
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Thief River Falls, Minnesota, 미국, 56701
- 모집하지 않고 적극적으로
- Sanford Thief River Falls Medical Center
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Virginia, Minnesota, 미국, 55792
- 모집하지 않고 적극적으로
- Essentia Health Virginia Clinic
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Worthington, Minnesota, 미국, 56187
- 모집하지 않고 적극적으로
- Sanford Worthington Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
Ancillary studies Given PO Given Reishi mushroom extract PO
다른 이름들:
|
|
실험적: 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
다른 이름들:
Ancillary studies Given PO Given Reishi mushroom extract PO
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in fatigue scores
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in quality of life
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Stacy D. D'Andre, MD, Mayo Clinic in Rochester
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MC221002
- MC221002 (기타 식별자: Mayo Clinic in Rochester)
- NCI-2023-06578 (레지스트리 식별자: CTRP (Clinical Trials Reporting Program))
- 23-005266 (기타 식별자: Mayo Clinic Institutional Review Board)
- MNCCTN032 (기타 식별자: Minnesota Cancer Clinical Trials Network)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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