NCT05561023尚未招募1 期
Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 14
- 主要终点
- AE, SAE and DLT, MTD (if any), RP2D
研究概览
简要总结
To evaluate the safety and tolerance of Hawthorn red pigment in the treatment of cancer pain
Determine the maximum tolerated dose (MTD, if any) of Hawthorn red pigment and the recommended dose for phase II clinical study (RP2D)
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-80 years with malignant tumor confirmed by pathology;
- •Refractory cancer pain, that is, patients coexist: 1) digital score of persistent pain ≥ 4 points and / or number of eruptive pain ≥ 3 times / day; 2) Following the relevant guidelines for cancer pain treatment, the pain relief of patients treated with opioids alone and / or combined with adjuvant analgesics for 1-2 weeks is still unsatisfactory and / or intolerable adverse reactions occur;
- •Patients who need chemotherapy, long-term hormone, targeted therapy or bisphosphate therapy had stable anti-tumor therapy before randomization;
- •Patients or their nursing staff can fill in the survey form;
- •Correctly understand and cooperate with medical staff in medication guidance;
- •No mental illness;
- •ECOG-ps ≤ 3 points; 8) Did not participate in the drug test (including the test drug) within one month before the test;
- •The subjects volunteered and signed the informed consent.
排除标准
- •patient is diagnosed with non cancerous pain or pain of unknown cause;
- •Postoperative pain of patients;
- •Patients with paralytic intestinal obstruction;
- •Patients with metastatic brain cancer;
- •Patients with opioid allergy / addiction;
- •Abnormal laboratory results with obvious clinical significance, such as creatinine ≥ upper limit of normal value, ALT or AST ≥ 2.5 times of upper limit of normal value (liver metastasis patients or primary liver cancer ≥ 5 times of upper limit of normal value), or child C level of liver function;
- •Patients who cannot take drugs orally;
- •Uncontrollable nausea and vomiting;
- •Patients with a history of gastritis and gastric ulcer;
- •Patients who need to use nonsteroidal drugs and steroid hormone drugs for analgesia;
- •Diabetes patients who can't control blood sugar stably;
- •Pregnant and lactating women; Subjects with pregnancy plans within 1 month after the trial (including male subjects);
- •Alcoholics;
- •Patients with cognitive impairment;
- •Patients with severe depression;
- •Diseases and conditions that other researchers consider not to be included.
研究组 & 干预措施
Phase Ⅰ a clinical study
Other
"3 + 3" dose escalation scheme
干预措施: Hawthorn red pigment (Drug)
结局指标
主要结局
AE, SAE and DLT, MTD (if any), RP2D
时间窗: 1 month
Occurrence and frequency of AE, SAE and DLT, MTD (if any), RP2D, Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
次要结局
- Average pain score(1 month)
研究者
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