Hawthorn Red Combined Refractory Cancer PainPhase 1NCT05561023
Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
A Phase 1 study testing Hawthorn red pigment in people with Hawthorn Red Combined Refractory Cancer Pain, run by Fujian Cancer Hospital.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hawthorn Red Combined Refractory Cancer Pain
- What is being tested?
- Hawthorn red pigment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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)
- Being tested
- Hawthorn red pigment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hawthorn red pigmentDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Phase Ⅰ a clinical study | Other | "3 + 3" dose escalation scheme Receives: Drug: Hawthorn red pigment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
Average pain score
Change in average pain score (NRS 0-10, 0 = painless, 10 = most painful)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hawthorn Red Combined Refractory Cancer PainStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561023
- Sponsor's protocol ID
- HBG-01/SYLT-024
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅰa Clinical Study of Hawthorn Red Pigment Combined With Standard Analgesic for Refractory Cancer Pain
- ClinicalTrials.gov ID
- NCT05561023
- Acronym / sponsor ID
- HBG-01/SYLT-024
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase Ⅰ a clinical study | Other | Drug: Hawthorn red pigment"3 + 3" dose escalation scheme |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hawthorn red pigmentFor 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 | Drug | Phase Ⅰ a clinical study |
Primary outcome
AE, SAE and DLT, MTD (if any), RP2D
Time frame: 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
1 secondary outcome
Average pain score
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hawthorn red pigment in people with Hawthorn Red Combined Refractory Cancer Pain, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE, SAE and DLT, MTD (if any), RP2D (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.