Chemotherapy-Induced Peripheral NeuropathyNCT07572461
A Single-Arm, Prospective Study of Papaverine for the Treatment of Refractory Peripheral Neuropathy Induced by Taxane-Based Chemotherapy
A study testing Papaverine hydrochloride injection in people with Chemotherapy-Induced Peripheral Neuropathy and Refractory Chemotherapy-Induced Peripheral Neuropathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often long-lasting side effect of cancer treatment. Patients may experience numbness, tingling, pain, burning sensations, weakness, or difficulty with walking and daily activities. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Refractory Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-Induced Peripheral Neuropathy
- What is being tested?
- Papaverine hydrochloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age 18 to 75 years.
- Histologically or cytologically confirmed malignancy.
- Prior treatment with a taxane-containing chemotherapy regimen, including but not limited to paclitaxel, docetaxel, or nab-paclitaxel, with completion of chemotherapy at least 4 weeks before enrollment.
- Persistent, clinically significant peripheral neuropathy mainly attributed to taxane-based chemotherapy, with NCI-CTCAE v5.0 sensory neuropathy grade ≥ 2.
- Failure of at least one standard treatment for chemotherapy-induced peripheral neuropathy, such as duloxetine ≥ 60 mg/day, pregabalin ≥ 150 mg/day, or gabapentin ≥ 900 mg/day, for at least 4 weeks, defined as lack of symptom improvement or intolerance to treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Adequate organ function, including hematologic, hepatic, and renal function within acceptable ranges.
- Willingness to participate and ability to provide written informed consent.
Who cannot join
- Peripheral neuropathy due to causes other than chemotherapy, such as uncontrolled diabetes mellitus (HbA1c > 7.0%), severe renal insufficiency, vitamin B12 deficiency, thyroid dysfunction, or history of alcohol abuse.
- Known hypersensitivity to papaverine or any of its components.
- Contraindications to papaverine, such as complete atrioventricular block.
- Current use of other investigational drugs that may affect neurological function.
- Pregnant or breastfeeding women.
- Severe hepatic or renal dysfunction, defined as ALT or AST > 3 × upper limit of normal or serum creatinine > 2 × upper limit of normal.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often long-lasting side effect of cancer treatment. Patients may experience numbness, tingling, pain, burning sensations, weakness, or difficulty with walking and daily activities. Paclitaxel-related CIPN is especially common, and current treatment options are limited. For patients whose symptoms do not improve with standard therapies such as duloxetine, pregabalin, or gabapentin, there is an important unmet clinical need. Papaverine is a vasodilator and smooth muscle relaxant that may improve blood flow in the small vessels supplying nerves. Based on the hypothesis that impaired microcirculation and ischemia may contribute to CIPN, papaverine may help relieve symptoms and support nerve recovery. Preliminary clinical observations by the investigators suggested that papaverine injection may rapidly improve numbness and weakness in some patients with refractory paclitaxel-induced CIPN.This is a prospective, single-center, single-arm, open-label phase II study designed to evaluate the preliminary efficacy and safety of papaverine injection in patients with refractory paclitaxel-induced peripheral neuropathy. Eligible participants are adults aged 18 to 75 years with histologically or cytologically confirmed malignancy, prior treatment with a paclitaxel-containing regimen, persistent clinically significant neuropathy of grade 2 or higher, and failure of at least one standard treatment for CIPN. Participants will receive papaverine hydrochloride 120 mg diluted in 100 mL normal saline by intravenous infusion once daily, given as 1 treatment day followed by 6 rest days, with 7 days defined as one cycle. Up to 3 cycles of treatment may be given if patients benefit and tolerate therapy well.The main goal of the study is to assess improvement in patient-reported sensory neuropathy symptoms using the EORTC QLQ-CIPN20 sensory subscale. Secondary objectives include changes in overall neuropathy symptoms, physician-assessed neuropathy grade, quality of life, and safety. Exploratory assessments include nerve conduction findings and inflammatory biomarkers. The study aims to enroll approximately 43 patients and will provide early evidence on whether papaverine may be a useful treatment option for patients with refractory paclitaxel-induced CIPN.
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Refractory Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-Induced Peripheral Neuropathy
- Being tested
- Papaverine hydrochloride injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papaverine hydrochloride injectionDrug
Intervention Description:
Papaverine hydrochloride injection will be administered at a dose of 120 mg diluted in 100 mL of 0.9% sodium chloride solution by intravenous infusion once daily. Treatment consists of 1 day of administration followed by 6 days of rest, with 7 days defined as one cycle. Patients who demonstrate clinical benefit and tolerate treatment may receive up to 3 cycles. Concomitant use of stable-dose neurotrophic agents is allowed, while initiation of new treatments that may affect neuropathy is prohibited.
| Study group | Role | What they receive |
|---|---|---|
| Papaverine Treatment | Experimental | Not described Receives: Drug: Papaverine hydrochloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in EORTC QLQ-CIPN20 sensory scale score
Measured: From baseline to Day 15 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinuo Tan, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572461
- Sponsor's protocol ID
- 2026-Lunshenyan-0272
- Status last verified
- May 2026
- First submitted
- 21 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective Study of Papaverine for the Treatment of Refractory Peripheral Neuropathy Induced by Taxane-Based Chemotherapy
- ClinicalTrials.gov ID
- NCT07572461
- Acronym / sponsor ID
- 2026-Lunshenyan-0272
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Refractory Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-Induced Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 7 May 2026 (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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often long-lasting side effect of cancer treatment. Patients may experience numbness, tingling, pain, burning sensations, weakness, or difficulty with walking and daily activities. Paclitaxel-related CIPN is especially common, and current treatment options are limited. For patients whose symptoms do not improve with standard therapies such as duloxetine, pregabalin, or gabapentin, there is an important unmet clinical need. Papaverine is a vasodilator and smooth muscle relaxant that may improve blood flow in the small vessels supplying nerves. Based on the hypothesis that impaired microcirculation and ischemia may contribute to CIPN, papaverine may help relieve symptoms and support nerve recovery. Preliminary clinical observations by the investigators suggested that papaverine injection may rapidly improve numbness and weakness in some patients with refractory paclitaxel-induced CIPN.This is a prospective, single-center, single-arm, open-label phase II study designed to evaluate the preliminary efficacy and safety of papaverine injection in patients with refractory paclitaxel-induced peripheral neuropathy. Eligible participants are adults aged 18 to 75 years with histologically or cytologically confirmed malignancy, prior treatment with a paclitaxel-containing regimen, persistent clinically significant neuropathy of grade 2 or higher, and failure of at least one standard treatment for CIPN. Participants will receive papaverine hydrochloride 120 mg diluted in 100 mL normal saline by intravenous infusion once daily, given as 1 treatment day followed by 6 rest days, with 7 days defined as one cycle. Up to 3 cycles of treatment may be given if patients benefit and tolerate therapy well.The main goal of the study is to assess improvement in patient-reported sensory neuropathy symptoms using the EORTC QLQ-CIPN20 sensory subscale. Secondary objectives include changes in overall neuropathy symptoms, physician-assessed neuropathy grade, quality of life, and safety. Exploratory assessments include nerve conduction findings and inflammatory biomarkers. The study aims to enroll approximately 43 patients and will provide early evidence on whether papaverine may be a useful treatment option for patients with refractory paclitaxel-induced CIPN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Papaverine Treatment | Experimental | Drug: Papaverine hydrochloride injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 75 years.
- Histologically or cytologically confirmed malignancy.
- Prior treatment with a taxane-containing chemotherapy regimen, including but not limited to paclitaxel, docetaxel, or nab-paclitaxel, with completion of chemotherapy at least 4 weeks before enrollment.
- Persistent, clinically significant peripheral neuropathy mainly attributed to taxane-based chemotherapy, with NCI-CTCAE v5.0 sensory neuropathy grade ≥ 2.
- Failure of at least one standard treatment for chemotherapy-induced peripheral neuropathy, such as duloxetine ≥ 60 mg/day, pregabalin ≥ 150 mg/day, or gabapentin ≥ 900 mg/day, for at least 4 weeks, defined as lack of symptom improvement or intolerance to treatment.
Key exclusion criteria (7 listed)
- Peripheral neuropathy due to causes other than chemotherapy, such as uncontrolled diabetes mellitus (HbA1c > 7.0%), severe renal insufficiency, vitamin B12 deficiency, thyroid dysfunction, or history of alcohol abuse.
- Known hypersensitivity to papaverine or any of its components.
- Contraindications to papaverine, such as complete atrioventricular block.
- Current use of other investigational drugs that may affect neurological function.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Papaverine hydrochloride injectionIntervention Description: Papaverine hydrochloride injection will be administered at a dose of 120 mg diluted in 100 mL of 0.9% sodium chloride solution by intravenous infusion once daily. Treatment consists of 1 day of administration followed by 6 days of rest, with 7 days defined as one cycle. Patients who demonstrate clinical benefit and tolerate treatment may receive up to 3 cycles. Concomitant use of stable-dose neurotrophic agents is allowed, while initiation of new treatments that may affect neuropathy is prohibited. | Drug | Papaverine Treatment |
Primary outcome
Change from baseline in EORTC QLQ-CIPN20 sensory scale score
Time frame: From baseline to Day 15 (end of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Papaverine hydrochloride injection in people with Chemotherapy-Induced Peripheral Neuropathy and Refractory Chemotherapy-Induced Peripheral Neuropathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 7 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: opening soon, as of the sponsor's last update on 7 May 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinuo Tan (+86 13805753262, tan0yi0nuo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in EORTC QLQ-CIPN20 sensory scale score (time frame: From baseline to Day 15 (end of treatment)). 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 7 May 2026.