Chemotherapy-induced Peripheral NeuropathyPhase 2NCT04970121
Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy
A Phase 2 study testing Duloxetine in people with Chemotherapy-induced Peripheral Neuropathy and Pain, run by Yan Yang, MD, Ph.D at 1 site in China.
Trial summary
The study is to evaluate the efficacy and safety of duloxetine in Chinese solid tumor patients with taxanes-induced painful peripheral neuropathy. Duloxetine will be given to patients who have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy, Pain, Solid Tumor
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2021to 1 Dec 2027
- Phase
- Phase 2
- 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
- Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
- Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
- Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center;
- Patients must received treatment with a chemotherapy regimen containing taxanes;
- Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
- Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2;
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- Expected survival of ≥ 3 months;
- Screening values at screening meet the following requirements: (no blood components, cell growth factors, leukocyte-lifting drugs, platelet-lifting drugs, anemia-correcting drugs, etc. are allowed within 14 days prior to obtaining laboratory tests); Complete blood count: neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count (PLT) ≥ 90 × 109/L, hemoglobin (Hb) ≥ 90 g/L; Liver function: glutamic aminotransferase (AST), alanine aminotransferase (ALT) and total serum bilirubin (TBIL) ≤ 2 times the upper limit of normal range (ULN) Renal function: serum creatinine (Cr) ≤ ULN or creatinine clearance (CCr) ≥ 80 mL/min (applying the standard Cockcroft -Gault formula);
- Female patients who are non-lactating and must have a negative pregnancy test result;
- Patients of childbearing potential must agree to use effective contraception for at least 30 days after signing the informed consent to the last dose.
- Note: Concomitant use of selected analgesics (e.g., opioids, acetaminophen, aspirin, and other NSAIDs) is permitted, but only patients receiving a stable dose during the two weeks prior to enrollment may participate.
Who cannot join
- Patients with known hypersensitivity to duloxetine or any of the inactive ingredients in the product;
- Patients on other concomitant medications known to affect 5-hydroxytryptamine (5-HT) levels;
- Patients who must take monoamine oxidase inhibitors for antidepressant treatment；
- Patients with the presence of active brain or meningeal metastases；
- Patients with the presence of uncontrolled closed-angle glaucoma；
- Patients with the presence of neuropathy caused by any type of nerve compression；
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- The presence of mental illness, epilepsy, mania, suicidal depression, dementia or alcohol or drug abuse that may have an impact on compliance with trial requirements;
- The presence of comorbid cardiovascular disease, including but not limited to: (1) New York Heart Association (NYHA) criteria ≥ grade 2 heart failure; (2) severe/unstable angina pectoris; (3) myocardial infarction or cerebrovascular accident within 6 months prior to first dose; (4) atrial fibrillation and supraventricular or ventricular arrhythmias requiring treatment; (5) pre-existing symptomatic superior vena cava syndrome; (6) corrected QT interval (QTc) > 450 ms (men); QTc > 470 ms (women); (7) hypertensive disease not controlled by antihypertensive medication: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study；
- Patients are excluded from the study if investigator/sponsor believes that participation in the study is not in the subject's best interest.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jing Liu
Bengbu, Anhui, 233004
Jing Liu, M.D., +86-0552-3086178, 15805692769@163.com
Yan Yang, M.D., Ph.D.
About this study
Official title: A Single-Center, Single-Arm Clinical Trail Evaluating Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy
The study is to evaluate the efficacy and safety of duloxetine in Chinese solid tumor patients with taxanes-induced painful peripheral neuropathy. Duloxetine will be given to patients who have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and at least 4 on a scale of 0 to 10 points, representing average chemotherapy-induced pain, after taxanes treatment. Patient-reported pain severity, functional interference, emotion condition and quality of Life will be assessed weekly using corresponding scales. Blood samples will be collected from each enrolled subjects before the start of treatment, and the potential biomarkers in predicting duloxetine efficacy or safety will be explored by genomic profiling.
- Being tested
- Duloxetine
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Pain, Duloxetine, Taxanes, Solid tumor
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Chemotherapy containing taxanes
Duloxetine, tablets, 20mg as starting dose and up to 60mg as maximum dose, once daily.
Taxanes is used according to manual instruction and patient condition.
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine arm | Experimental | Chemotherapy regimens consisting of taxanes will be used according to treatment specifications. Subjects require therapeutic intervention for painful peripheral neuropathy will receive duloxetine 20 mg (orally, once daily) as the starting dose for 1 cycle of 7 days; the current dose will be maintained for effective pain control (NRS ≤ 3 points) and increased by 20 mg at the next cycle assessment for ineffective pain control (NRS > 3 points) up to a maximum dose of 60 mg (orally, once daily). Duloxetine administration will be maintained until the uncontrolled pain (under the condition of treatment with duloxetine at its maximum dose), intolerable toxicity, completed antineoplastic therapy or subject loss of visit, death, withdrawal of informed consent, or other conditions occur. The administration of duloxetine is up to a maximum of 12 weeks. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Scale title: Brief Pain Inventory Short Form (BPI-SF). Description: Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine).
Measured: Once every 7 days after treatment initiation.
Secondary outcomes (3)
Quality of Life Score
Scale title: Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) Description: Items in FACT/GOG-Ntx are scored using an 5-point numeric rating scale (0, not at all; 4, very much).
Measured: Once every 7 days after treatment initiation.
Function Score
Scale title: Brief Pain Inventory Short Form (BPI-SF). Description: Degree of pain-related functional interference is based on partial items in the BPI-SF and scored using an 11-point numeric rating scale, (0, does not interfere; 10, completely interferes).
Measured: Once every 7 days after treatment initiation.
Anxiety and depression Score
Scale 1 title: Hamilton Anxiety Rating Scale (HAM-A) Description: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Scale 2 title: Hamilton Depression Rating Scale (HDRS17) Description: HDRS17 uses a 5-point scale of 0 to 4 for most items and a 3-point scale of 0 to 2 for a few items, and higher scores mean a worse symptom. The total scores less than 7 or 7 are indicative of the absence of depression or being normal, 8-16 consider mild depression, 17-23 suggest moderate depression and scores 24 or over are indicative of severe depression.
Measured: Once every 7 days after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start21 Aug 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Duloxetine treatment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Yang, MD, Ph.D
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Yang, MD, Ph.D, The First Affiliated Hospital of Bengbu Medical University
- Investigators
- Yan Yang, M.D.,Ph.D, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970121
- Sponsor's protocol ID
- BYEC20210701
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2021
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Single-Arm Clinical Trail Evaluating Efficacy and Safety of Duloxetine in Chinese Solid Tumor Patients With Taxanes-induced Painful Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04970121
- Acronym / sponsor ID
- BYEC20210701
- Keywords
- Chemotherapy-induced Peripheral Neuropathy, Pain, Duloxetine, Taxanes, Solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yan Yang, MD, Ph.DUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Jul 2021 (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.
The study is to evaluate the efficacy and safety of duloxetine in Chinese solid tumor patients with taxanes-induced painful peripheral neuropathy. Duloxetine will be given to patients who have grade 1 or higher sensory neuropathy according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and at least 4 on a scale of 0 to 10 points, representing average chemotherapy-induced pain, after taxanes treatment. Patient-reported pain severity, functional interference, emotion condition and quality of Life will be assessed weekly using corresponding scales. Blood samples will be collected from each enrolled subjects before the start of treatment, and the potential biomarkers in predicting duloxetine efficacy or safety will be explored by genomic profiling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Duloxetine treatment
| Arm | Type | Receives |
|---|---|---|
| Duloxetine arm | Experimental | Drug: DuloxetineChemotherapy regimens consisting of taxanes will be used according to treatment specifications. Subjects require therapeutic intervention for painful peripheral neuropathy will receive duloxetine 20 mg (orally, once daily) as the starting dose for 1 cycle of 7 days; the current dose will be maintained for effective pain control (NRS ≤ 3 points) and increased by 20 mg at the next cycle assessment for ineffective pain control (NRS > 3 points) up to a maximum dose of 60 mg (orally, once daily). Duloxetine administration will be maintained until the uncontrolled pain (under the condition of treatment with duloxetine at its maximum dose), intolerable toxicity, completed antineoplastic therapy or subject loss of visit, death, withdrawal of informed consent, or other conditions occur. The administration of duloxetine is up to a maximum of 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study;
- Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender;
- Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center;
- Patients must received treatment with a chemotherapy regimen containing taxanes;
- Patients must have ≥ grade 1 sensory chemotherapy-induced peripheral neuropathy (CIPN) with NRS ≥ 4/10 according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v.5.0 grading scale
Key exclusion criteria (10 listed)
- Patients with known hypersensitivity to duloxetine or any of the inactive ingredients in the product;
- Patients on other concomitant medications known to affect 5-hydroxytryptamine (5-HT) levels;
- Patients who must take monoamine oxidase inhibitors for antidepressant treatment；
- Patients with the presence of active brain or meningeal metastases；
- Patients with the presence of uncontrolled closed-angle glaucoma；
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 |
|---|---|---|
| DuloxetineAlso: Chemotherapy containing taxanesDuloxetine, tablets, 20mg as starting dose and up to 60mg as maximum dose, once daily. Taxanes is used according to manual instruction and patient condition. | Drug | Duloxetine arm |
Primary outcome
Pain Score
Time frame: Once every 7 days after treatment initiation.
Scale title: Brief Pain Inventory Short Form (BPI-SF). Description: Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine).
3 secondary outcomes
Quality of Life Score
Time frame: Once every 7 days after treatment initiation.
Function Score
Time frame: Once every 7 days after treatment initiation.
Anxiety and depression Score
Time frame: Once every 7 days after treatment initiation.
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 8 Sep 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.
Yan Yang, M.D.,Ph.D principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Duloxetine in people with Chemotherapy-induced Peripheral Neuropathy and Pain, run by Yan Yang, MD, Ph.D at 1 site 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jing Liu, M.D. (+86-0552-3086178, 15805692769@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: Once every 7 days after treatment initiation.). 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 8 Sep 2026.