Duloxetine + Neurofeedback for Peripheral Neuropathy

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sarah Prinsloo

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. ^{1 2 3 4 5}

Is 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. ^{1 6 7 8 9}

How 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. ^{1 2 3 4 10}

Research Team

Sarah Prinsloo

Principal Investigator

M.D. Anderson Cancer Center

Eligibility 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

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.

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

Treatment Details

Interventions

• Duloxetine (Serotonin and Norepinephrine Reuptake Inhibitor)
• Neurofeedback Training (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Group III (duloxetine) Experimental Treatment 3 Interventions

Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.

Group II: Group II (neurofeedback training) Experimental Treatment 3 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 Treatment 4 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 Canada for the following indications:

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 Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Harris Health System (LBJ) Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3107

Patients Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Findings from Research

Duloxetine has been shown to be effective in managing painful diabetic neuropathy (PDN), demonstrating significant benefits over placebo and pregabalin based on a systematic review of 23 studies, 8 of which were of high quality.

While duloxetine was effective compared to placebo, its superiority over amitriptyline and pregabalin needs further investigation, as current evidence is limited to only one trial for each comparison.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine in Painful Diabetic Neuropathy: A Systematic Review. Hossain, SM., Hussain, SM., Ekram, AR.[2022]

Duloxetine is effective in providing at least 50% pain relief for patients with painful diabetic neuropathy and fibromyalgia, with a number needed to treat (NNT) of approximately 6, based on a review of six trials involving 1,696 patients over 12 to 13 weeks.

While duloxetine showed fewer withdrawals due to lack of efficacy compared to placebo, it did lead to more withdrawals due to adverse events, such as nausea and somnolence, indicating that while it is effective, some patients may experience side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. Sultan, A., Gaskell, H., Derry, S., et al.[2022]

Duloxetine, a medication for diabetic peripheral neuropathic pain, showed significant pain reduction in Chinese patients at weeks 1, 2, and 4, although the overall primary endpoint was not statistically significant after 12 weeks.

The safety profile of duloxetine was consistent with previous studies, with common side effects including nausea and somnolence, indicating it is generally safe for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Gao, Y., Ning, G., Jia, WP., et al.[2022]

Duloxetine, administered at either 60 mg twice daily or 120 mg once daily, was found to be safe and well-tolerated in 449 patients with diabetic peripheral neuropathic pain over a 28-week period, with low rates of discontinuation due to adverse events.

Both dosages of duloxetine resulted in significant improvements in pain relief, as measured by the Brief Pain Inventory and Clinical Global Impression of Severity scales, indicating its efficacy in treating diabetic peripheral neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine for patients with diabetic peripheral neuropathic pain: a 6-month open-label safety study. Raskin, J., Wang, F., Pritchett, YL., et al.[2022]

A systematic review of seven randomized controlled trials involving 645 patients found that duloxetine was not significantly more effective than placebo for both the treatment and prevention of chemotherapy-induced peripheral neuropathy (CIPN).

The safety profile of duloxetine was also similar to that of placebo, indicating that there is currently limited evidence to support its use in CIPN, highlighting the need for more rigorous studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duloxetine for prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN): systematic review and meta-analysis. Chow, R., Novosel, M., So, OW., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Duloxetine in Painful Diabetic Neuropathy: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Duloxetine for painful diabetic neuropathy and fibromyalgia pain: systematic review of randomised trials. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Duloxetine for patients with diabetic peripheral neuropathic pain: a 6-month open-label safety study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Diabetic peripheral neuropathic pain: recognition and management. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Duloxetine versus routine care in the long-term management of diabetic peripheral neuropathic pain. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Maintaining efficacy in the treatment of diabetic peripheral neuropathic pain: role of duloxetine. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Intensive monitoring of duloxetine: results of a web-based intensive monitoring study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

An open-label 52-week clinical extension comparing duloxetine with routine care in patients with diabetic peripheral neuropathic pain. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Duloxetine for prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN): systematic review and meta-analysis. [2023]