Back to resultsPhase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
Primary Purpose
Hawthorn Red Combined Refractory Cancer Pain
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hawthorn red pigment
Sponsored by
About this trial
This is an interventional treatment trial for Hawthorn Red Combined Refractory Cancer Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Phase Ⅰ a clinical study
Arm Description
"3 + 3" dose escalation scheme
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Average pain score
Change in average pain score (NRS 0-10, 0 = painless, 10 = most painful)
Full Information
NCT ID
NCT05561023
First Posted
September 12, 2022
Last Updated
September 26, 2022
Sponsor
Fujian Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05561023
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hawthorn Red Combined Refractory Cancer Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Phase Ⅰ a clinical study
Arm Type
Other
Arm Description
"3 + 3" dose escalation scheme
Intervention Type
Drug
Intervention Name(s)
Hawthorn red pigment
Intervention 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
Primary Outcome Measure Information:
Title
AE, SAE and DLT, MTD (if any), RP2D
Description
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Average pain score
Description
Change in average pain score (NRS 0-10, 0 = painless, 10 = most painful)
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
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