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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Once every 7 days after treatment initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Once every 7 days after treatment initiation. |
| Function Score |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Liu, M.D. | Contact | +86-0552-3086178 | 15805692769@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Yang, M.D.,Ph.D | The First Affiliated Hospital of Bengbu Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jing Liu | Recruiting | Bengbu | Anhui | 233004 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Duloxetine treatment
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|
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). |
| 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. | Once every 7 days after treatment initiation. |
| D006571 |
| Heterocyclic Compounds |