OncologyPhase 4NCT04261920
Clinical Trial Scheme of Huangqi Guizhi Wuwu Decoction
A Phase 4 study testing Huangqi Guizhi Wuwu decoction in people with Oncology, run by Jiangsu Famous Medical Technology Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oncology
- What is being tested?
- Huangqi Guizhi Wuwu decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2020to 2 Mar 2023
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage (according to CSCO guidelines for diagnosis and treatment of colorectal cancer) or III stage, IV stage (metastatic lesions have been radical resection); 2. Patients who are suitable for receiving oxaliplatin plus capecitabine regimen as adjuvant chemotherapy for 6 months, the cumulative dose of oxaliplatin are expected to exceed 520mg/m2 at least; 3. Aged from 18 to 75 years old, males or females; 4. ECOG score ranges from 0 to 1 5. Seven days before treatment, the functions of major organs (heart, liver, kidney, bone marrow) meet the following criteria:
- Standard of blood routine examination (without blood transfusion within 14 days) i. Hemoglobin (HB) ≥90g/L； ii. Absolute Neutrophil Count(ANC) ≥1.5×109/L；. iii. Platelet (PLT) ≥80×109/L.
- Biochemical examination should meet the following standards:
- Total bilirubin(TBIL) ≤1.5 times upper normal limit(ULN);
- Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) ≤2.5 times ULN；
- ③Serum creatinine （Cr）≤1.5 times ULN or Creatinine clearance(CCr) ≥60ml/min; 6.Expected survival time≥12 months; 7. For subjects who have used other chemotherapeutic drugs in the past, they need to go through a clearance period of at least 4 weeks before entering this trial.
- 8. The patient who will sign the informed consent form
Who cannot join
- Patients with original nervous system diseases, including peripheral neuropathy and central neuropathy;
- Those who are allergic to oxaliplatin or the ingredients of this traditional Chinese medicine;
- Clinical symptoms of patients with severe damp-heat syndrome of colorectal cancer include: dry mouth, bitter taste in the mouth, sticky sensation in mouth, yellow urine, dry stool, red tongue with yellow ,thick and greasy fur;
- Patients with neurological disease caused by electrolyte disorders or diabetes;
- Patients with symptoms of nerve compression caused by various causes;
- At the same time, patients who receive other neuroprotective therapy, including nerve growth factor, vitamin B and calcium-magnesium mixture;
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- Patients who were treated with oxaliplatin for chemotherapy before;
- Patients who need radiotherapy within half a year after operation;
- Pregnant or lactation period women;
- Patients with cognitive impairment or psychosis;
- Other patients the investigator considers unsuitable for inclusion.
Trial locations and contacts
2 sites in 1 country.
Gu Yanhong, PhD contact
China2 sites, 2 recruiting
- Not yet recruiting
Affiliated Hospital of Nanjing University of TCM
Nanjing, Jiangsu, 210029
Shu Peng, PhD, 86-13851701678
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Gu Yanhong, PhD, 86-13813908678
Chen Xiaofeng, PhD
About this study
Official title: Study on Efficacy and Safety of Huangqi Guizhi Wuwu Decoction Treatment for Oxaliplatin Induced Peripheral Neurotoxicity: a Protocol for a Randomized, Controlled, Double-blind, Multi-center Trial
To evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.
Read the detailed description
The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.
- Conditions
- Oncology
- Being tested
- Huangqi Guizhi Wuwu decoction
- Keywords
- Oxaliplatin induced peripheral neurotoxicity, Clinical curative effect
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huangqi Guizhi Wuwu decoctionDrug
Also called Huangqi Guizhi Wuwu decoction placebo
The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).
The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).
| Study group | Role | What they receive |
|---|---|---|
| Single decoction group: Huangqi Guizhi Wuwu decoction | Experimental | The dosage of granules: Sheng huangqi granule 5.5g/bag, Guizhi granule 0.9g/bag, Baishao granule 1.6g/bag, Ganjiang granule 1.7g/bag, Dazao granule 7g/bag. Take twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles) Receives: Drug: Huangqi Guizhi Wuwu decoction |
| Simulator group: Huangqi Guizhi Wuwu decoction Placebo | Placebo comparator | The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles) Receives: Drug: Huangqi Guizhi Wuwu decoction |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of chronic neurotoxicity
Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment
Measured: 3 years
Secondary outcomes (7)
incidence of acute neurotoxicity
Difference in the incidence of acute neurotoxicity
Measured: 3 years
Time of occurrence of chronic toxicity
Time of occurrence of chronic toxicity to grade 2 and 3
Measured: 3 years
main symptoms
Incidence and severity of main symptoms
Measured: 3 years
Recovery time of neurotoxicity
Recovery time of grade 2 and 3 neurotoxicity
Measured: 3 years
Cumulative dose of oxaliplatin and the proportion of patients
Cumulative dose of oxaliplatin and the proportion of patients who stop using oxaliplatin because of neurotoxicity
Measured: 3 years
myelosuppression
Incidence of myelosuppression
Measured: 3 years
nausea, vomiting, diarrhea, and hand-foot syndrome
Incidence of nausea, vomiting, diarrhea, and hand-foot syndrome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start3 Jan 2020
- Primary completion2 Jan 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261920
- Sponsor's protocol ID
- FM-P8-2018060101
- Status last verified
- Mar 2020
- First submitted
- 6 Feb 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wei XM, Chen XF, Shu P, Jiang ZW, Wu XY, Zou X, Chen K, Shen B, Hu WW, Lu W, Shen WX, Li L, Wang JY, Zhao FJ, Yin QF, Cheng HB, Gu YH. Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial. Medicine (Baltimore). 2020 May 29;99(22):e19923. doi: 10.1097/MD.0000000000019923.
PubMed 32481364
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Efficacy and Safety of Huangqi Guizhi Wuwu Decoction Treatment for Oxaliplatin Induced Peripheral Neurotoxicity: a Protocol for a Randomized, Controlled, Double-blind, Multi-center Trial
- ClinicalTrials.gov ID
- NCT04261920
- Acronym / sponsor ID
- FM-P8-2018060101
- Conditions
- Oncology
- Keywords
- Oxaliplatin induced peripheral neurotoxicity, Clinical curative effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 2 Jan 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 10 Feb 2020 (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 efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity.
Detailed description
The purpose of this study is to evaluate whether the preventive effect of Huangqi Guizhi Wuwu decoction on oxaliplatin induced peripheral neurotoxicity is better than that of simulator, and to provide evidence-based medicine basis for the clinical promotion of single medicine granule. This trial purpose is to evaluate the efficacy and safety of Huangqi Guizhi Wuwu decoction in preventing oxaliplatin induced peripheral neurotoxicity. This trial design type is a randomized, controlled, double-blind, multicenter clinical study was conducted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage
| Arm | Type | Receives |
|---|---|---|
| Single decoction group: Huangqi Guizhi Wuwu decoction | Experimental | Drug: Huangqi Guizhi Wuwu decoctionThe dosage of granules: Sheng huangqi granule 5.5g/bag, Guizhi granule 0.9g/bag, Baishao granule 1.6g/bag, Ganjiang granule 1.7g/bag, Dazao granule 7g/bag. Take twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles) |
| Simulator group: Huangqi Guizhi Wuwu decoction Placebo | Placebo comparator | Drug: Huangqi Guizhi Wuwu decoctionThe control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Patients with colorectal cancer diagnosed by histopathological examination; patients after radical resection of colorectal cancer confirmed by histopathological examination, staged as high-risk II stage (according to CSCO guidelines for diagnosis and treatment of colorectal cancer) or III stage, IV stage (metastatic lesions have been radical resection); 2. Patients who are suitable for receiving oxaliplatin plus capecitabine regimen as adjuvant chemotherapy for 6 months, the cumulative dose of oxaliplatin are expected to exceed 520mg/m2 at least; 3. Aged from 18 to 75 years old, males or females; 4. ECOG score ranges from 0 to 1 5. Seven days before treatment, the functions of major organs (heart, liver, kidney, bone marrow) meet the following criteria:
- Standard of blood routine examination (without blood transfusion within 14 days) i. Hemoglobin (HB) ≥90g/L； ii. Absolute Neutrophil Count(ANC) ≥1.5×109/L；. iii. Platelet (PLT) ≥80×109/L.
- Biochemical examination should meet the following standards:
- ③Serum creatinine （Cr）≤1.5 times ULN or Creatinine clearance(CCr) ≥60ml/min; 6.Expected survival time≥12 months; 7. For subjects who have used other chemotherapeutic drugs in the past, they need to go through a clearance period of at least 4 weeks before entering this trial.
- 8. The patient who will sign the informed consent form
Key exclusion criteria (11 listed)
- Patients with original nervous system diseases, including peripheral neuropathy and central neuropathy;
- Those who are allergic to oxaliplatin or the ingredients of this traditional Chinese medicine;
- Clinical symptoms of patients with severe damp-heat syndrome of colorectal cancer include: dry mouth, bitter taste in the mouth, sticky sensation in mouth, yellow urine, dry stool, red tongue with yellow ,thick and greasy fur;
- Patients with neurological disease caused by electrolyte disorders or diabetes;
- Patients with symptoms of nerve compression caused by various causes;
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 |
|---|---|---|
| Huangqi Guizhi Wuwu decoctionAlso: Huangqi Guizhi Wuwu decoction placeboThe experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles). The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles). | Drug | Simulator group: Huangqi Guizhi Wuwu decoction Placebo, Single decoction group: Huangqi Guizhi Wuwu decoction |
Primary outcome
incidence of chronic neurotoxicity
Time frame: 3 years
Differences in the incidence of chronic neurotoxicity of grade 2 and above during and after treatment
7 secondary outcomes
incidence of acute neurotoxicity
Time frame: 3 years
Time of occurrence of chronic toxicity
Time frame: 3 years
main symptoms
Time frame: 3 years
Recovery time of neurotoxicity
Time frame: 3 years
Cumulative dose of oxaliplatin and the proportion of patients
Time frame: 3 years
myelosuppression
Time frame: 3 years
nausea, vomiting, diarrhea, and hand-foot syndrome
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Derived from this study: PubMed 32481364Wei XM, Chen XF, Shu P, Jiang ZW, Wu XY, Zou X, Chen K, Shen B, Hu WW, Lu W, Shen WX, Li L, Wang JY, Zhao FJ, Yin QF, Cheng HB, Gu YH. Study on efficacy and safety of Huangqi Guizhi Wuwu decoction treatment for oxaliplatin induced peripheral neurotoxicity: A protocol for a randomized, controlled, double-blind, multicenter trial. Medicine (Baltimore). 2020 May 29;99(22):e19923. doi: 10.1097/MD.0000000000019923.
- Individual participant dataSharing planned: Undecided
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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.
Gu Yanhong, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huangqi Guizhi Wuwu decoction in people with Oncology, run by Jiangsu Famous Medical Technology Co., Ltd. at 2 sites in China.
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 7 inclusion and 11 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 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Chen Haibo, PhD (86-025-85811005, hbcheng@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of chronic neurotoxicity (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261920, which also lists 1 linked publication.
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 9 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.