NCT05623852招募中不适用
A Phase II Trial for Oligo-Fucoidan in Cancer Cachexia and Sarcopenia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Body Weight
研究概览
简要总结
Fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients.
详细描述
Cancer cachexia is characterized by anorexia, skeletal muscle atrophy, and systemic inflammation. Fucoidan extracted from brown algae exhibits anti-inflammatory and anticancer activities. In addition, fucoidan also ameliorates tumour and chemotherapy-induced muscle atrophy and -related cachectic symptoms in vivo and in vitro. To evaluate the effect of fucoidan in cancer cachexia or sarcopenia in cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed patients with stage III-IV non-small cell lung cancer, colorectal carcinoma, head and neck cancer, nasopharyngeal cancer, or pancreatic carcinoma, who are not eligible for surgery, and interventional treatment .
- •Chemotherapy regimen include platinum-based drugs and Gemcitabine based drugs;
- •For patients who are being treated with chemotherapy, the chemotherapy regimen should be confined to the regimens specified in the protocol; and the chemotherapy regimen, in general, are not allowed to be changed during the study period;
- •Patients are conscious and able to cooperate with the doctor to complete the disease-related examinations and evaluations;
- •ECOG performance status (PS) 0-3 for those who are not treated with chemotherapy; and ECOG PS 0-2 for those who are being treated with chemotherapy;
- •Expected survival period is more than 3 months;
- •Male or female aged 20 - 90 years;
- •Patients who are willing to participate in the study and sign the informed consent form.
排除标准
- •Patients who are being treated with chemotherapy, the chemotherapy regimen is not among the regimens specified in the protocol;
- •Patients with cachexia caused by other reasons, e.g. severe hepatic dysfunction [Aspartate transaminase(AST)/Cerealthirdtransaminase(ALT) >5 times the ULN], severe renal dysfunction (Cr >1.5 times the ULN), uncontrolled thyroid disease, New York Heart Association (NYHA) class III-IV heart failure, AIDS etc.;
- •Any condition that may hinder the subject's completion of the study, including but not limited to severe uncontrollable organic diseases or infection, unstable angina pectoris, congestive heart failure, etc.;
- •Known or suspected diagnosis of metastatic encephaloma;
- •Patients present with an ECOG score>2 and require treatment of chemotherapy;
- •Patients who are currently included in other clinical trials on antineoplastic drugs;
- •Patients who are not able to provide the Informed Consent Form (ICF);
- •Expected survival period is less than 4 months;
- •Female patient is pregnant or breast-feeding, and those patients at childbearing age who are not willing to use methods of contraception (including males);
- •Patients with symptomatic, uncontrolled nervous disorders, mental illness or psychiatric disorder;
- •Any condition, in the investigator's opinion, is not in the best interest of the subject (e.g., harming the subject's health) or potentially interferes with the evaluation of treatment according to this protocol.
结局指标
主要结局
Body Weight
时间窗: 0 day, 60th day, and 90th day Body weight change
Body Weight Change. (kilograms)
次要结局
- Lean Mass Measured by Densitometry(0 day, 60th day, and 90th day)
- Biomarkers TNF-alpha, IL-6, IGF-1 and IGFBP-3.(0 day, 60th day, and 90th day)
- Muscle Strength as Measured by Grip Strength.(0 day, 60th day, and 90th day)
- Quality of life as assessed using the FACIT-F Patient Reported Outcome assessments(0 day, 60th day, and 90th day)
- Appetite(0 day, 60th day, and 90th day)
- Resting Energy Expenditure(0 day, 60th day, and 90th day)
- Functional Performance(0 day, 60th day, and 90th day)
- 1-repetition Max. Strength(0 day, 60th day, and 90th day)
- Food Diary Calorie Count(0 day, 60th day, and 90th day)
研究者
研究点 (4)
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