MC231007 Fucoidan For Patients With Chemotherapy-Related Fatigue: A Double-Blind, Randomized, Placebo-Controlled Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in fatigue, weeks 1-8
研究概览
简要总结
This phase II trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI), gynecological (GYN), breast, or lung cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI, GYN, breast, or lung cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the efficacy of fucoidan versus (vs.) placebo in preventing fatigue as assessed by a single-item measure of fatigue at 8 weeks following the initiation of platinum-based doublet/triplet.
SECONDARY OBJECTIVES:
I. To estimate 1) changes in fatigue via the single item measure of fatigue from baseline to week 16 2) the Global Impression of Change at week 8 and week 16 and 3) the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale at week 8 and week 16.
II. To evaluate the frequency and severity of toxicity as reported by the patient on the Symptom Experience Diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Research staff, other than pharmacy, are blinded and will dispense the fucoidan or placebo to the patient at the site.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
- •Starting platinum-based doublet/triplet therapy for gynecologic, gastrointestinal, breast, or lung cancer in the non-curative setting, with at least 16 weeks of chemotherapy and/or immunotherapy planned prior to registration; able to start study treatment ≤ 7 days prior to starting chemotherapy
- •Life expectancy at least 6 months
- •Hemoglobin ≥ 10 g/dL (obtained ≤ 30 days prior to registration)
- •Creatinine ≤ 1.5 x upper normal limit (UNL) OR calculated creatinine clearance ≥ 50 ml/min using the Cockcroft-Gault (obtained ≤ 30 days prior to registration)
- •Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 1.5 x UNL; [≤ 5 x upper limit of normal (ULN) for patients with liver involvement] (obtained ≤ 30 days prior to registration)
- •Ability to complete patient questionnaires alone or with assistance and to be willing to be contacted by study staff
- •Provide written informed consent
- •Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •Willing to use a highly effective method of contraception from the first dose of study medication through 30 days after the last dose of study medication, for persons of childbearing potential or persons able to father a child only
- •Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
排除标准
- •Known hypersensitivity to fucoidan or seaweed products
- •Currently using any other pharmacologic agents to specifically treat fatigue including psychostimulants or antidepressants. Note: Antidepressants used to treat items other than fatigue (such as hot flashes or depression) are allowed if the patient has been on a stable dose for ≥ 1 month prior to registration and plans to continue such for 8 weeks. Exercise is allowed
- •Psychiatric disorder such as untreated/uncontrolled depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia (defined per medical history)
- •Surgery that required general anesthetic ≤ 4 weeks prior to registration
- •Malnutrition, active infection, severe depression, significant pulmonary disease, and/or cardiovascular disease that the attending physician feels could be causing the patient's fatigue
- •Use of any over-the-counter herbal/dietary supplement marketed for fatigue or energy (for example, products containing ginseng, rhodiola rosea, guarana, or anything called an "adaptogen"), including current use of fucoidan
- •Current use of warfarin, heparin, enoxaparin, or a novel anticoagulant or known bleeding disorder/abnormal prothrombin time (PT)/partial thromboplastin time (PTT) at baseline
- •Current use of bevacizumab
- •Untreated thyroid conditions
- •Use of chemotherapy and/or immunotherapy ≤ 90 days prior to registration
- •Unwillingness to follow study related procedures
- •Inability to provide informed consent
研究组 & 干预措施
Arm 1 (fucoidan)
Patients receive fucoidan PO TID for 8 weeks. After completion of fucoidan, patients then cross over into Arm 2 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.
干预措施: Biospecimen Collection (Procedure)
Arm 1 (fucoidan)
Patients receive fucoidan PO TID for 8 weeks. After completion of fucoidan, patients then cross over into Arm 2 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.
干预措施: Oligo-fucoidan (Dietary Supplement)
Arm 2 (placebo)
Patients receive placebo PO TID for 8 weeks. After completion of placebo, patients then cross over into Arm 1 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.
干预措施: Questionnaire Administration (Other)
Arm 1 (fucoidan)
Patients receive fucoidan PO TID for 8 weeks. After completion of fucoidan, patients then cross over into Arm 2 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.
干预措施: Questionnaire Administration (Other)
Arm 2 (placebo)
Patients receive placebo PO TID for 8 weeks. After completion of placebo, patients then cross over into Arm 1 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.
干预措施: Biospecimen Collection (Procedure)
Arm 2 (placebo)
Patients receive placebo PO TID for 8 weeks. After completion of placebo, patients then cross over into Arm 1 for 8 weeks. Patients may optionally undergo blood sample collection during screening and on study.
干预措施: Placebo Administration (Drug)
结局指标
主要结局
Change in fatigue, weeks 1-8
时间窗: Baseline to 8 weeks
Will be assessed using self-reported fatigue over the past week. Fatigue is rated on a scale of 0-10 where 0=no fatigue at all and 10=fatigue as bad as it can be. Fatigue scores will be compared between arms.
次要结局
- Change in fatigue, weeks 9-16(Baseline to 16 weeks)
- Change in the symptoms(Baseline to 16 weeks)
- Change in Subjective Global Impression of Change scores(Week 8 and Week 16)
- Incidence of rates of symptoms(Up to 16 weeks)