A Cohort Study to Evaluate the Efficacy of Beta-Glucan or Beta-Glucan Compound (Combined With Glutamine and Immunoglobulin) Supplement in Patients With Metastatic Cancers Undergoing Chemotherapy
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 5th cycle, from day 7 of 4th cycle of chemotherapy
研究概览
简要总结
Immunity of cancer patients is an important issue. According to cancer immunity, it can be divided into three phases: clearance phase, equilibrium phase, and escape phase (cancer cells can avoid the recognition of immune cells). Βeta-glucans is extracted from yeast, it can increase immune function and drive of hematopoietic stem cells in animals and clinical trials. Glutamine can increase the repair of oral and intestinal mucosa of patients receiving chemical and radiation therapy and can increase the lymphocytes of patients. Colostrum contains IgA, IgG, IgM, etc., known to protect the baby Cancer patients who are infected with intestinal bacteria and undergo systemic chemotherapy are less immune than normal adults.
Investigators will compare β-glucan, glutamine, and colostrum immunoglobulin powder with β-glucan and control group, each group has 30 people, and observe the side effects and blood of patients under standard chemotherapy. The performance of the immune system, such as helpers and cytotoxic T cells and NK cells, and to observe the differences in treatment interruption or delay rates and treatment rates.
详细描述
Experiment theme / background:
Cancer immune surveillance is considered to be an important host protection process to inhibit carcinogenesis and to maintain cellular homeostasis. In the interaction of host and tumor cells, three essential phases have been proposed: elimination, equilibrium, and escape.
In the elimination stage, a small portion of cancer cells can be eliminated by immune reactions. Direct cancer and innate immune system interaction including natural killer cells (NK), dendritic cells (DC), macrophages, polymorphonuclear leukocytes (PM including neutrophils, eosinophils, and basophils), mast cells and cytotoxic T lymphocytes, directly target cancer cells. NK cells, DC, PMN, mast cells, and macrophages are first-line effectors to damaged cells and cancer cells. NK-T cells and γδ T cells play roles as both innate and adaptive components, through close interactions with cells of the adaptive immune system, such as CD4+ and CD8+ T lymphocytes with cytotoxic effects and memory. In addition to direct cancer/innate immune system interactions, a large number of molecules released due to cancer cell death, may function as damage-associated molecular patterns (DAMP) and interact with innate immune cells. Those cancer-derived DAMP include both intracellular molecules and extracellular matrix (ECM) molecules released from apoptotic and necrotic tumor cells.
However, cancer cells show immune tolerance and go in to escape stage. Currently, programmed death-1 (PD-1) in T cells and programmed death ligands 1 and 2 in cancer cells overexpression was proved as one of the mechanisms of immune tolerance of cancer cells. The cytotoxic T-lymphocyte-associated antigen -4 (CTLA-4) is another negative regulator of immune reaction in cancer patients. Immune therapy including anti-PD1, anti-PD-L1, anti-CTLA4 medicines, developed and showed clinical benefit in many cancer types, including melanoma, renal cell carcinoma, head and neck cancer, non-small cell lung cancer, etc. It shows us that if investigators can break immune tolerance in cancer patients, cancer can be controlled.
Beta-glucan (long polymer ([1,6] B-d-glucopyranosoyl-[1,3] Bd-glucopyranose, PGG) is isolated from Baker's yeast (Saccharomyces cerevisiae).8 Preparation of purified yeast beta-glucan sphere is commercially available in the form of whole glucan particles (Wellmune, WGPs) as a food supplement. Further efforts resulted in the development of a water-soluble, pharmaceutical-grade yeast beta-glucan whose biological effects have been extensively studied in vivo. Beta-glucan particle is consumed by macrophages after being transported from the lumen of the small intestine through Peyer's patches. The macrophage degrades the beta-glucan (a pro-drug) to its bioactive fractions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
this trial is single-blind clinical trial
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with metastatic cancer receiving systemic chemotherapy
- •Age ≥20 years
- •Chemotherapy drugs include platinum drugs (cisplatin, carboplatin, oxaliplatin), irinotecan / topotecan, paclitaxel (docetaxel), fluorouracil (5-FU), and alkylating drugs (such as cyclophosphamide)
排除标准
- •Early cancer patients.
- •Patients receiving systemic chemotherapy or large-area radiation therapy 6 months before chemotherapy.
- •The patient had a history of allergies to β-glucan or glutamine.
- •Patients with liver dysfunction not associated with cancer. (GOT> 2 × ULN; GPT> 2 × ULN)
- •Patients with abnormal renal function (creatinine over 2 mg / dl)
- •Age <20 years
结局指标
主要结局
the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 5th cycle, from day 7 of 4th cycle of chemotherapy
时间窗: 14-21 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 6th cycle, from day 1 of 6th cycle of chemotherapy
时间窗: 7 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 5th cycle, from day 1 of 5th cycle of chemotherapy
时间窗: 7 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at 2 month from C6D22
时间窗: 9 -10 weeks
total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent.
the change of total white blood cells, neutrophils, and lymphocytes at day 14 of 2nd cycle, from day 7 of 2nd cycle of chemotherapy
时间窗: 7days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 3rd cycle, from day 14 of 2nd cycle of chemotherapy
时间窗: 14-21 days
the units of white blood cells, neutrophils, and lymphocytes are /ul
the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 3rd cycle, from day 1 of 3rd cycle of chemotherapy
时间窗: 7 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of total white blood cells, neutrophils, and lymphocytes at day 7 of 4th cycle, from day 7 of 3rd cycle of chemotherapy
时间窗: 21-28 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of total white blood cells, neutrophils, and lymphocytes at day 22 of 6th cycle, from day 7 of 6th cycle of chemotherapy
时间窗: 15 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of total white blood cells, neutrophils, and lymphocytes at 2nd month after chemotherapy, from day 22 of 6th cycle of chemotherapy
时间窗: 63 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
the change of lymphocyte surface markers percentage at day 7 of 4th cycle of chemotherapy, from day 14 of 2nd chemotherapy
时间窗: 5-7 weeks
the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i
the change of lymphocyte surface markers percentage at day 22 of 6th cycle of chemotherapy, from day 7 of 4th cycle of chemotherapy
时间窗: 8-10 weeks
the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i
the change of lymphocyte surface markers percentage at 2 month after 6th cycle of chemotherapy, from day 22 of 6th cycle of chemotherapy
时间窗: 5 weeks
the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i
the change of total white blood cells, neutrophils, and lymphocytes at day 1 of 6th cycle, from day 7 of 5th cycle of chemotherapy
时间窗: 14-21 days
the units of white blood cells, neutrophils, and lymphocytes are /ul.
change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at C4D7 from C2D7
时间窗: 6-8 weeks
total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions. The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent.
change of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC-quality-of-life questionnaire cervical cancer module (EORTC-QLQ-CX24 [Taiwan version]) score at C6D22 from C4D7
时间窗: 8-10 weeks
total 54 questions. 1-4 points for each EORTC QLQ-C30 and EORTC QLQ-CX24 (Taiwan version) are continue question list, that contain total 54 questions The questionnaire is divided into two parts.One is that the higher the score, the more obvious the uncomfortable symptoms.One is that the higher the score, the better the state, for example:1. The overall health score of the self-assessment in this week is 7 points, 1 point means very poor and 7 points means excellent.2. Self-assess the overall quality of life during the week. 1 point means very poor and 7 points means excellent.
the change of lymphocyte surface markers percentage at day 7 of 2nd chemotherapy, from baseline.
时间窗: 4-5 weeks
the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i
the change of lymphocyte surface markers percentage at day 14 of 2nd chemotherapy, from day 7 of 2nd chemotherapy
时间窗: 7 days
the lymphocytes surface markers including:CD3, CD4, CD8, CD20, CD28, CD279, CD16, CD56, CD158a/h, CD158b, CD158e, CD158f, CD158i
次要结局
- analysis overall survival(2 years)