None listed
Conditions
Brief summary
This trial aims to assess whether treatment with duloxetine results in a reduction in chronic neuropathic symptoms experienced as a result of neurotoxic chemotherapy treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have had daily symptoms of peripheral neuropathy for at least 3 months after completing chemotherapy. Study details Participants in this study will be randomly allocated (by chance) to receive the drug duloxetine or placebo (inactive treatment) for 8 weeks. After a two week washout period, participants will switch conditions and receive placebo or study drug for another eight weeks. Those allocated to the study drug arm will be started on duloxetine 30 mg once daily, increasing to 60mg daily for weeks 2-7, and back to 30mg daily for week 8. Participants randomised to the control group will receive a daily placebo capsule to the dosage matching the treatment arm. Placebo tablets will look identical to duloxetine, and participants will not know which treatment they are receiving. All participants in the trial will receive duloxetine for 8 weeks. All participants will have liver and kidney function tests performed at baseline and at monthly intervals. Clinical examination, nerve conduction and excitability studies, functional assessment (nine-hole peg test) and self-report measures will be undertaken at baseline and after each 8 week treatment period. Patients will be asked to keep a symptom diary, which will be checked at each study visit.
Interventions
Duloxetine will be administered for eight weeks via oral capsules. Participants will receive 30mg duloxetine per day for the first week of the active arm of the trial, uptitrating to 60mg for the following six weeks. Participants will then receive 30mg duloxetine for the final week of the active arm. There will be a two week wash-out period before crossover to the second study arm.
Adherence will be monitored via capsule counts at each study visit. Participants will also be asked whether they h
Duloxetine will be administered for eight weeks via oral capsules. Participants will receive 30mg duloxetine per day for the first week of the active arm of the trial, uptitrating to 60mg for the following six weeks. Participants will then receive 30mg duloxetine for the final week of the active arm. There will be a two week wash-out period before crossover to the second study arm. Adherence will be monitored via capsule counts at each study visit. Participants will also be asked whether they have missed any doses during weekly monitoring phone calls. If a participant reports missing doses, strategies for remembering to take the study medication (e.g. taking the study medication with meals, using reminder notes) will be suggested.
Sponsors
Prince of Wales Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed