The use of duloxetine for the treatment of chemotherapy-induced peripheral neuropathy

Phase 2

Recruiting

• Conditions: Chemotherapy-induced peripheral neuropathy; Neurological - Other neurological disorders; Cancer - Any cancer

• Registration Number: ACTRN12617000139370
• Lead Sponsor: Prince of Wales Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Daily symptoms of peripheral neuropathy for at least 3 months after completing chemotherapy.
2. History of neuropathic symptoms beginning in extremities following chemotherapy, e.g.: dysesthesia, burning pain, hyperalgesia of lower extremities, shooting or lancinating pain, aching, or tingling.
3. At least grade 1 sensory neuropathy via the National Cancer Institute Common Terminology Criteria for Adverse Effects (NCI CTCAE) version 4.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
5. Willingness and ability to give written informed consent, and willingness to participate in and comply with the study.

Exclusion Criteria

1. Currently receiving chemotherapy, or have received chemotherapy within the last 3 months.
2. Inability to speak English.
3. Pregnancy or lactation. Contraception is required in pre-menopausal female patients.
4. Calculated creatinine clearance less than 60 mL/min.
5. AST (aspartate aminotransferase) greater than or equal to 3 times upper limit of normal (greater than or equal to 135 U/L).
6. Total bilirubin greater than 25 umol/L.
7. INR (international normalised ratio) greater than 1.4.
8. Diabetes mellitus, type 1 and 2.
9. HIV infection.
10. Significant degenerative or familial neurologic disorder known to cause peripheral neuropathy.
11. Currently receiving active treatment for glaucoma.
12. Severe depression, suicidality, bipolar disorder, schizophrenia, major eating disorder, at the discretion of the treating clinician.
13. Alcohol abuse or dependence.
14. Current use of any class of antidepressant or antipsychotic medication. At least 14 days must have passed since last use of antidepressant medication. Medication should not have been discontinued without medical consultation.
15. Current use of CYP1A2 inhibitors, including:
- fluvoxamine
- ciprofloxacin
- enoxacin
- fluoroquinolones
- verapramil
- vemurafenib
- amiodarone
- interferon
- artemisinin
- atazanavir
16. Current use of anticoagulants.
17. Current treatment for peripheral neuropathy or neuropathic pain. Any treatments for these conditions must be ceased at least 14 days prior to randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported neuropathic symptom scores on the FACT/GOG-NTx neurotoxicity subscale. A difference of 2.8 points on this measure will be considered to be a clinically significant difference.[Baseline, and at 4 and 8 weeks after intervention commencement.]

Secondary Outcome Measures

Name	Time	Method
Total Neuropathy Score (TNS)[Baseline, and at 8 weeks after intervention commencement.];Grooved pegboard test[Baseline, and at 8 weeks after intervention commencement.];Brief Pain Inventory Short Form (BPI-SF)[Baseline, and at 8 weeks after intervention commencement.];Hospital Anxiety and Depression Scale (HADS)[Baseline, and at 8 weeks after intervention commencement.]