Clinical trial NCT05561023: Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
Official title: Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hawthorn Red Combined Refractory Cancer Pain
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-09-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-80 years with malignant tumor confirmed by pathology;
2. 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;
3. Patients who need chemotherapy, long-term hormone, targeted therapy or bisphosphate therapy had stable anti-tumor therapy before randomization;
4. Patients or their nursing staff can fill in the survey form;
5. Correctly understand and cooperate with medical staff in medication guidance;
6. No mental illness;
7. ECOG-ps ≤ 3 points; 8) Did not participate in the drug test (including the test drug) within one month before the test;
8. The subjects volunteered and signed the informed consent.

Exclusion Criteria:

1. patient is diagnosed with non cancerous pain or pain of unknown cause;
2. Postoperative pain of patients;
3. Patients with paralytic intestinal obstruction;
4. Patients with metastatic brain cancer;
5. Patients with opioid allergy / addiction;
6. 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;
7. Patients who cannot take drugs orally;
8. Uncontrollable nausea and vomiting;
9. Patients with a history of gastritis and gastric ulcer;
10. Patients who need to use nonsteroidal drugs and steroid hormone drugs for analgesia;
11. Diabetes patients who can't control blood sugar stably;
12. Pregnant and lactating women; Subjects with pregnancy plans within 1 month after the trial (including male subjects);
13. Alcoholics;
14. Patients with cognitive impairment;
15. Patients with severe depression;
16. Diseases and conditions that other researchers consider not to be included.

Primary outcomes:
measure: AE, SAE and DLT, MTD (if any), RP2D
timeFrame: 1 month
Secondary outcomes:
measure: Average pain score
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: