What side effects are associated with this type of intervention?

Duloxetine, a commonly used SNRI for treating peripheral neuropathy, can cause side effects such as somnolence, headaches, sexual dysfunction, nausea, vomiting, and hepatocellular hepatitis. Patients are advised to take it with food to minimize nausea. Neurofeedback Training, which involves EEG-based brain wave modulation, is generally considered safe with minimal side effects, though some patients may experience mild discomfort or fatigue during sessions. Other similar treatments, like gabapentin and pregabalin, may cause dizziness, somnolence, and peripheral edema.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Neuropathy, particularly focusing on pharmacologic options. Duloxetine, an SNRI, is approved for diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. Other SNRIs like venlafaxine have also shown efficacy in treating neuropathic pain. Additionally, anticonvulsants such as gabapentin and pregabalin are commonly used and FDA-approved for various neuropathic pain conditions. While neurofeedback training is not FDA-approved specifically for Peripheral Neuropathy, it represents a promising non-pharmacologic approach under investigation. These treatments aim to alleviate pain and improve quality of life for patients suffering from neuropathic conditions.

What other types of research exist?

Promising novel alternatives for treating Peripheral Neuropathy include: 1) Pregabalin and Gabapentin, which are anticonvulsants that reduce neurotransmitter release and have shown efficacy in multiple trials. 2) Tricyclic Antidepressants (e.g., Amitriptyline, Nortriptyline) which have been effective in pain relief for neuropathic conditions. 3) Venlafaxine, another Serotonin-Norepinephrine Reuptake Inhibitor, which has shown positive results in some studies. 4) Non-pharmacological options like Transcutaneous Electrical Nerve Stimulation (TENS) and Acupuncture, which have been explored for their pain-relieving properties. These alternatives provide a range of options that can be discussed with a healthcare provider.

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Serotonin and Norepinephrine Reuptake Inhibitor

Duloxetine + Neurofeedback for Peripheral Neuropathy

Phase 2

Recruiting

Led By Sarah Prinsloo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain score >= 4 on a 0-10 numeric pain scale and/or grade 1-4 neuropathic pain according to the National Cancer Institute's 4 point grading scale

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Must not have

Patients with active central nervous system (CNS) disease, such as clinically-evident metastases or leptomeningeal disease, dementia, or encephalopathy

Patients who have ever been diagnosed with bipolar disorder or schizophrenia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-treatment

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Duloxetine may cause side effects like nausea, dry mouth, sleepiness, fatigue, constipation, loss of appetite and increased sweating. Neurofeedback is generally considered low-risk but might include mild discomfort from wearing sensors or temporary changes in mood.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level is 4 or higher, or I have nerve pain rated from mild to severe.

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I can take care of myself and am up and about more than half of the day.

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I have had nerve pain symptoms for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active brain metastases or severe brain disorders.

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I have been diagnosed with bipolar disorder or schizophrenia.

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I am currently taking antipsychotic medication.

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I am aware of any reasons I shouldn't receive DL treatment.

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I have nerve damage not caused by chemotherapy.

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I am currently taking duloxetine for nerve pain.

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I have thoughts of harming myself.

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I have had a head injury or seizures in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Quality Assessment Scale (PQAS) unpleasantness score

Secondary study objectives

Baseline brain signatures as predictors of response to NFB and to DL

Change in PQAS unpleasantness score

Change in cancer-related symptoms

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Neurofeedback

2019

Completed Phase 3

~1100

Duloxetine

FDA approved

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Duloxetine, a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI), works by increasing the levels of these neurotransmitters in the brain, enhancing the descending inhibitory pain pathways and thereby reducing pain. Neurofeedback Training uses EEG to measure brain wave activity and teaches patients to modulate their brain waves, which can help reduce the perception of pain and improve quality of life. These treatments are significant for Peripheral Neuropathy patients as they address both the chemical and neurological aspects of pain, providing a more comprehensive approach to pain management.

Pharmacotherapy for diabetic peripheral neuropathy pain and quality of life: A systematic review.