To hear about similar clinical trials, please enter your email below
Trial Title:
Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
NCT ID:
NCT05561023
Condition:
Hawthorn Red Combined Refractory Cancer Pain
Conditions: Official terms:
Cancer Pain
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Hawthorn red pigment
Description:
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
Arm group label:
Phase Ⅰ a clinical study
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
October 1, 2022
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Fujian Cancer Hospital
Agency class:
Other
Source:
Fujian Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05561023
