Duloxetine + Neurofeedback for Peripheral Neuropathy
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Antipsychotics, Duloxetine
Disqualifiers: CNS disease, Bipolar, Schizophrenia, others
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?This trial tests if combining duloxetine and neurofeedback training is better at treating nerve damage from chemotherapy than using either treatment alone. Duloxetine helps balance brain chemicals to reduce pain, and neurofeedback training helps patients control their brain activity to lessen pain.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot change your pain medication regimen during the study. You also cannot be taking antipsychotic medications or duloxetine for peripheral neuropathy.
What data supports the effectiveness of the drug Duloxetine for treating peripheral neuropathy?
Research shows that Duloxetine is effective in reducing pain for people with diabetic peripheral neuropathy, a type of nerve damage caused by diabetes. It works by increasing the levels of certain chemicals in the brain that help reduce pain.
12345Is the combination of Duloxetine and Neurofeedback safe for treating peripheral neuropathy?
Duloxetine, also known as Cymbalta, has been studied for safety in treating diabetic peripheral neuropathic pain, with research showing it is generally safe for long-term use up to 52 weeks. Safety data from these studies suggest that duloxetine is well-tolerated in humans, but specific safety information about combining it with neurofeedback is not available.
16789How is the drug Duloxetine + Neurofeedback unique for treating peripheral neuropathy?
Duloxetine is unique because it is a reuptake inhibitor of serotonin and norepinephrine, which are chemicals in the brain that help reduce pain, and it has been shown to be effective for diabetic peripheral neuropathic pain. Combining it with neurofeedback, a technique that trains the brain to change its activity, may offer a novel approach to managing peripheral neuropathy by addressing both chemical and neurological aspects of pain.
123410Eligibility Criteria
This trial is for patients who have nerve damage (peripheral neuropathy) caused by chemotherapy. They must have had symptoms for at least 3 months, not be changing pain meds during the study, and can't already be taking duloxetine for neuropathy. Participants should understand English, consent to the study's requirements, and either visit a cancer center or agree to remote sessions if living within a 45-minute drive of one.Inclusion Criteria
My pain level is 4 or higher, or I have nerve pain rated from mild to severe.
If participants agree to the Remote Training Option, participants should be willing to download necessary software to their home computer
If participants agree to the Remote Training Option, participants should be willing to allow research staff remote access to their computer to run the neurofeedback program
+9 more
Exclusion Criteria
I have been diagnosed with bipolar disorder or schizophrenia.
I am currently taking antipsychotic medication.
I am aware of any reasons I shouldn't receive DL treatment.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive neurofeedback training and/or duloxetine for 5 weeks
5 weeks
3-5 visits per week (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Follow-up at 6 and 12 months
Participant Groups
The trial tests whether combining duloxetine—a drug that helps with depression and nerve pain—with neurofeedback training improves peripheral neuropathy more than each treatment alone. Neurofeedback uses brain wave monitoring to potentially reduce neuropathy symptoms and improve life quality.
3Treatment groups
Experimental Treatment
Group I: Group III (duloxetine)Experimental Treatment3 Interventions
Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
Group II: Group II (neurofeedback training)Experimental Treatment3 Interventions
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
Group III: Group I (neurofeedback training, duloxetine)Experimental Treatment4 Interventions
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
Duloxetine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Cymbalta for:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
🇪🇺 Approved in European Union as Cymbalta / Yentreve for:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathic Pain
- Fibromyalgia
- Stress Urinary Incontinence
🇨🇦 Approved in Canada as Cymbalta for:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Harris Health System (LBJ)Houston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Duloxetine in Painful Diabetic Neuropathy: A Systematic Review. [2022]To systematically review the evidence for duloxetine in the management of painful diabetic neuropathy (PDN).
Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. [2022]Duloxetine hydrochloride is a reuptake inhibitor of 5-hydroxytryptamine and norepinephrine used to treat depression, generalized anxiety disorder, neuropathic pain, and stress incontinence in women. We investigated the efficacy of duloxetine in painful diabetic neuropathy and fibromyalgia to allow comparison with other antidepressants.
Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. [2022]Duloxetine, a selective serotonin and noradrenaline reuptake inhibitor, has been shown to be effective in treatment of diabetic peripheral neuropathic pain and approved for the management of patients with diabetic peripheral neuropathic pain (DPNP) in the United States, European Union, and many other countries. This study assessed the efficacy and safety of duloxetine in Chinese patients with diabetic peripheral neuropathic pain.
Duloxetine for patients with diabetic peripheral neuropathic pain: a 6-month open-label safety study. [2022]Duloxetine is a relatively balanced and potent reuptake inhibitor of both serotonin and norepinephrine. Because these neurotransmitters play a role in pain inhibition, duloxetine was considered a possible treatment for diabetic peripheral neuropathic pain (DPNP). This study assessed the 6-month safety and tolerability of duloxetine in patients with DPNP; evaluation of efficacy was a secondary objective.
Diabetic peripheral neuropathic pain: recognition and management. [2015]The occurrence of diabetic peripheral neuropathy (DPN) is linked to poor glycemic control over time. While most people never develop diabetic peripheral neuropathic pain (DPNP) as a consequence of DPN, enough of them do that we must have effective options for the management of this disabling condition. Two years ago there were no formally approved medications for the treatment of DPNP, and now there are two medications with Food and Drug Administration approval for DPNP. One of these medications, duloxetine has been established to significantly improve pain and to address depression by its reuptake inhibition of norepinephrine and serotonin. This article examines the epidemiology of DPNP, its underlying pathogenesis, necessary evaluation methods, and treatment options available with a focus on the role of duloxetine.
Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain. [2022]Duloxetine hydrochloride is a dual reuptake inhibitor of both serotonin and norepinephrine. In the present open-label study, the safety of duloxetine at a fixed-dose of 60 mg twice daily (BID) for up to 52 weeks was evaluated and compared to routine care in the therapy of patients diagnosed with diabetic peripheral neuropathic pain (DPNP).
Maintaining efficacy in the treatment of diabetic peripheral neuropathic pain: role of duloxetine. [2021]Neuropathy is one of the most frequent complications of diabetes. Of all the symptoms associated with diabetic neuropathy, pain has the largest impact on sleep and quality of life. In the past few years further medications have been added to the available therapies for neuropathic pain. One of these medications, duloxetine hydrochloride (duloxetine), is a balanced and potent selective serotonin and norepinephrine reuptake inhibitor.
Intensive monitoring of duloxetine: results of a web-based intensive monitoring study. [2022]Duloxetine (Cymbalta(®)) is a serotonin (5-HT) and norepinephrine (NE) re-uptake inhibitor indicated for the treatment of depression, diabetic peripheral neuropathic pain and general anxiety disorder. The aim of this study is to gain insight in the user and safety profile of duloxetine in daily practice, reported by patients via a web-based intensive monitoring system during their first 6 months of use.
An open-label 52-week clinical extension comparing duloxetine with routine care in patients with diabetic peripheral neuropathic pain. [2022]To assess the safety of duloxetine at a fixed-dose of 60 mg twice daily (BID) for up to 52 weeks, and compare duloxetine with routine care in the management of patients with diabetic peripheral neuropathic pain (DPNP).
Duloxetine for prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN): systematic review and meta-analysis. [2023]Duloxetine has previously been reported to be promising in the setting of chemotherapy-induced peripheral neuropathy (CIPN). The aim of this study was to conduct a comprehensive systematic review and meta-analysis, on the use of duloxetine in prevention and treatment of CIPN.