NCT06706752招募中不适用
A Randomized, Blinded, Placebo-controlled Trial of Shengbai Oral Formula to Assess Safety and Alleviation of Adverse Effects in Patients With Cancer Undergoing Chemotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Brief Fatigue Inventory
研究概览
简要总结
The goal of this clinical trial is to assess whether Shengbai Oral Formula is a viable option for treatment of fatigue, pain, and neutropenia in patients undergoing their third cycle of chemotherapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age
- •A cancer diagnosis and scheduled to undergo at least three rounds of chemotherapy for curative or palliative intent
- •Chemotherapy is given at a minimum of every 2 weeks
- •At least 30 days past radiation therapy
- •Nonpregnant and use of method of contraception per the treating clinician standard of care
- •Life expectancy > 3 months
- •Stable on all herbal or complementary therapeutics for the past 30 days and agree to not include new complementary therapeutics until after study completion
- •Baseline ECOG ≤ 2
- •In the opinion of the investigator, the subject will be compliant and have a high probability of completing the study including all scheduled evaluations and required tests
排除标准
- •Abnormal ALT/AST: > 2.5 to 3 times normal range
- •Platelets < 75,000
- •Documentation of a bone marrow transplant
- •Documentation of brain metastases, diagnosis with other cancer, except skin cancer history with basal cell carcinoma, squamous carcinoma
- •Documentation of current seizure disorder
- •Documentation of new cardiac arrhythmias and myocardial infarction
- •Any active bacterial or viral infection, pneumonia, sepsis, active gastric ulcer, gastritis, nonhealing wound, intractable nausea or vomiting, diarrhea, bleeding disorder
- •Hyperthyroidism, connective tissue disease including systemic lupus erythematous, rheumatoid arthritis
- •Documentation of a current drug abuse disorder
- •Current participation in other clinical trial
结局指标
主要结局
Brief Fatigue Inventory
时间窗: 14 days
The Brief Fatigue Inventory (BFI) is used to assess the severity and impact of fatigue, including cancer-related fatigue. Fatigue scores on the BFI are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
次要结局
未报告次要终点
研究者
Amy Matecki
Principal Investigator and Holistic/Integrative Medicine Physician
Sutter Health
研究点 (2)
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