Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain

Phase 1

Not yet recruiting

• Conditions: Hawthorn Red Combined Refractory Cancer Pain
• Interventions: Drug: Hawthorn red pigment

• Registration Number: NCT05561023
• Lead Sponsor: Fujian Cancer Hospital

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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Study First Posted: 2022-09-30
• Last Update Posted: 2022-09-30
• Study Start: 2022-10-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase Ⅰ a clinical study	Hawthorn red pigment	"3 + 3" dose escalation scheme

Primary Outcome Measures

Name	Time	Method
AE, SAE and DLT, MTD (if any), RP2D	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

Secondary Outcome Measures

Name	Time	Method
Average pain score	1 month	Change in average pain score (NRS 0-10, 0 = painless, 10 = most painful)