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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Hawthorn Red Combined Refractory Cancer Pain
• Intervention / Treatment: Drug: Hawthorn red pigment

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Phase Ⅰ a clinical study; "3 + 3" dose escalation scheme

Drug: Hawthorn red pigment; For patients with refractory cancer pain who meet the enrollment conditions, on the basis of the clinician's normal adjustment of the analgesic regimen (the initial adjustment is the first day), the dose ramp up study of Hawthorn red pigment was started on the third day. The Hawthorn red dose group includes 10 tablets → 15 tablets → 20 tablets / time, orally, twice a day. "3 + 3" dose escalation scheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE, SAE and DLT, MTD (if any), RP2D	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average pain score	Change in average pain score (NRS 0-10, 0 = painless, 10 = most painful)	1 month

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: HBG-01/SYLT-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No