Can an antidepressant calm Chemotherapy's nerve pain?
NCT ID NCT04970121
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether duloxetine, a drug commonly used for depression, can reduce the painful nerve damage that some cancer patients experience after receiving taxane chemotherapy. The study enrolls adults with solid tumors who have at least moderate pain from this side effect. Participants take duloxetine daily for a period, and researchers track their pain levels, daily functioning, emotional well-being, and quality of life. The goal is to see if this drug offers a safe and effective way to ease this distressing symptom.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- duloxetine, an antidepressant that may also relieve nerve pain
- What this could lead to
- If duloxetine works, it could offer a new way to manage painful nerve damage caused by taxane chemotherapy, improving comfort and quality of life for cancer patients.
- What could go wrong
- This is a small, early-phase study without a placebo group, so results may not be definitive. Duloxetine can cause side effects like nausea, dizziness, or fatigue, and it may not relieve pain for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2021
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must sign an informed consent form (ICF) voluntarily and be able to understand and comply with the requirements of the study; 2. Patients must be 18 to 75 years of age (including cut-offs) on the date of signing the informed consent form, regardless of gender; 3. Patients must be diagnosed with malignant solid tumors by pathological histology or cytology in the central laboratory or study center; 4. Patients must received treatment with a chemotherapy regimen containing taxanes; 5. 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 6. Eastern Cooperative Oncology Group performance status (ECOG PS): 0-2; 7. Expected survival of ≥ 3 months; 8. 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); 9. Female patients who are non-lactating and must have a negative pregnancy test result; 10. 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. Exclusion Criteria: 1. Patients with known hypersensitivity to duloxetine or any of the inactive ingredients in the product; 2. Patients on other concomitant medications known to affect 5-hydroxytryptamine (5-HT) levels; 3. Patients who must take monoamine oxidase inhibitors for antidepressant treatment; 4. Patients with the presence of active brain or meningeal metastases; 5. Patients with the presence of uncontrolled closed-angle glaucoma; 6. Patients with the presence of neuropathy caused by any type of nerve compression; 7. 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; 8. 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; 9. Patients with other medical history or evidence of disease that has the potential to confound trial results are excluded from the study; 10. Patients are excluded from the study if investigator/sponsor believes that participation in the study is not in the subject's best interest.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chemotherapy-induced peripheral neuropathy are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Jing Liu
RECRUITINGBengbu, Anhui, 233004, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A single arm, open label, dose-escalation phase i and dose-expansion phase IIa clinical study to evaluate the feasibility, safety, and efficacy of allogeneic chimeric antigen receptor (CAR) Gamma-Delta t cells CAR001 in subjects with Relapsed/Refractory solid tumors
- The effect of stress ball use during femoral arterial sheath removal after coronary angiography on pain, anxiety, patient satisfaction, and hemodynamic parameters
- Retraining the senses to fight chemotherapy nerve damage
- A new imaging agent aims to make solid tumors visible on PET scans
- Can a radioactive antibody seek out and destroy Hard-to-Treat tumors?
- Retraining the senses to fight chemotherapy nerve damage