NCT00680667已完成1 期
Phase I Clinical Trial of Trametes Versicolor in Women With Breast Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Coriolus versicolor mushroom extract may slow the growth of cancer cells and may be an effective treatment for breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of coriolus versicolor extract in treating women with stage I, stage II, or stage III breast cancer who have finished radiation therapy.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of oral coriolus versicolor extract in women with stage I-III, estrogen receptor- and/or progesterone receptor-negative or positive (as of 1/26/2009), infiltrating ductal adenocarcinoma of the breast who have recently completed standard post-surgery radiotherapy.
Secondary
- To determine the feasibility of measuring changes in fatigue and quality of life of patients treated with this drug.
- To characterize the toxicity of this drug in these patients.
- To gather preliminary data that compare baseline and post-treatment immunologic measures, including differential blood counts (i.e., WBC), natural killer cell activity, phagocytic index, regulatory cell assay, T/B/NK cell population subset assays, peripheral blood mononuclear cell production of levels of interferon gamma, and tumor necrosis factor-alpha in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis, within the previous 12 months with Stage I-III, infiltrating ductal adenocarcinoma of the breast who have undergone surgery and chemotherapy and are able to begin study treatment within 5 days after the last dose of radiotherapy
- •Estrogen and/or progesterone receptor-negative or positive
- •Willing to eat consistent diet throughout the study, and avoid dietary sources of mushrooms
- •Willing to avoid taking any product containing Trametes versicolor, other immune modulating medicinal mushrooms, or other herbal products believed to have immune modulating effects, during radiotherapy and until completion of the subject's last clinic visit on the study.
- •Adequate organ function within 14 days of study enrollment including the following:
- •Adequate bone marrow reserve: White blood cells (WBC) ≥ 2,000/mm³, Platelet count ≥ 100,000/mm³, Hemoglobin ≥ 9 g/dL
- •Hepatic: Bilirubin ≤ 20% times upper limit of normal (ULN), Alkaline phosphatase ≤ 20% times ULN, AST and ALT ≤ 20% times ULN
- •Renal: Creatinine ≤ 20% times ULN
- •Nutritional status: Albumin ≥ 3.0 g/dL
- •Negative pregnancy test
- •Voluntary written consent before performance of any study-related procedure not part of the normal medical care
排除标准
- •Pregnant - Patients with reproductive potential must use an approved non-hormonal contraceptive method if appropriate during and for 4 weeks after the last dose of Trametes versicolor.
- •Known allergy to fungi, including mushrooms
- •Serious concurrent medical or psychiatric disorder (e.g., active infection or uncontrolled diabetes) that, in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study
- •Receipt of hematopoietic growth factors (e.g., Neupogen™, Epogen™) within the previous 4 weeks
- •Unwilling to maintain consistency in type and dose of concurrent complementary and alternative medicine therapies
- •Unwilling to discontinue excluded medications and supplements
研究组 & 干预措施
Trametes Versicolor
Experimental
Females with Stage I-III infiltrating ductal adenocarcinoma of the breast being treated with Trametes versicolor capsules for 6 weeks after receiving radiation therapy.
干预措施: Coriolus versicolor extract (Biological)
结局指标
主要结局
Maximum tolerated dose
时间窗: Up to 6 Weeks After Treatment
次要结局
- Quality of life(Over 6 Weeks)
- Fatigue(Over 6 Weeks)
- Symptom Assessment(Weekly and at 3 Week Follow-Up)
- comparison of immunologic measures(Baseline and Post-Treatment)
- NK cell activity(Over 6 weeks)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Mistletoe Lectin in Treating Patients With Refractory Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00006477European Organisation for Research and Treatment of Cancer - EORTC26
已完成
1 期
Mistletoe Lectin in Treating Patients With Advanced Solid Tumors That Have Not Responded to Previous TherapyUnspecified Adult Solid Tumor, Protocol SpecificNCT00006354European Organisation for Research and Treatment of Cancer - EORTC41
已完成
不适用
Effects of a natural ingredient-based vaginal gel on vaginal healthAsymptomatic women with ectopia and alterations of the vaginal microbiotaUrological and Genital DiseasesISRCTN77955077Instituto Palacios de Salud y Medicina de la Mujer21
已完成
1 期
Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid TumorsExtensive Stage Small Cell Lung CancerHereditary ParagangliomaMalignant ParagangliomaMetastatic Gastrointestinal Carcinoid TumorMetastatic PheochromocytomaRecurrent Breast CancerRecurrent Cervical CancerRecurrent Endometrial CarcinomaRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Neuroendocrine Carcinoma of the SkinRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent PheochromocytomaRecurrent Prostate CancerRecurrent Renal Cell CancerRecurrent Small Cell Lung CancerRecurrent Uterine SarcomaRegional Gastrointestinal Carcinoid TumorRegional PheochromocytomaStage III Cervical CancerStage III Endometrial CarcinomaStage III Neuroendocrine Carcinoma of the SkinStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage III Prostate CancerStage III Renal Cell CancerStage III Uterine SarcomaStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Endometrial CarcinomaStage IV Neuroendocrine Carcinoma of the SkinStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Prostate CancerStage IV Renal Cell CancerStage IV Uterine SarcomaStage IVA Cervical CancerStage IVB Cervical CancerThyroid Gland Medullary CarcinomaMale Breast CancerPancreatic Polypeptide TumorNCT01155258University of Southern California19
已完成
1 期
Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin LymphomaAdult Nasal Type Extranodal NK/T-cell LymphomaAngioimmunoblastic T-cell LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaNodal Marginal Zone B-cell LymphomaPeripheral T-cell LymphomaRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Hodgkin LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeSplenic Marginal Zone LymphomaWaldenstrom MacroglobulinemiaAnaplastic Large Cell LymphomaPost-transplant Lymphoproliferative DisorderNCT01075321Mayo Clinic58