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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
Hormonal (e.g., tamoxifen or Arimidex, etc.) and targeted (Tarceva and Avastin, etc.) therapies allowed as long as they will be continued during the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-treatment
Awards & highlights

Study Summary

This trial is testing whether duloxetine and neurofeedback training can help relieve symptoms of chemotherapy-induced peripheral neuropathy better than duloxetine or neurofeedback training alone.

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.Check my eligibility
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.See study design
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 am on hormonal or targeted cancer therapies and can continue them during the study.
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I can attend therapy at the cancer center, live close enough for home visits, or can go to a regional care center.
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I haven't had chemotherapy in the last 3 months.
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My nerve pain is due to chemotherapy, as confirmed by my doctor.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pain Quality Assessment Scale (PQAS) unpleasantness score
Secondary outcome measures
Baseline brain signatures as predictors of response to NFB and to DL
Change in PQAS unpleasantness score
Change in cancer-related symptoms
+3 more

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
Duloxetine
FDA approved
Neurofeedback
2019
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,786,857 Total Patients Enrolled
5 Trials studying Peripheral Neuropathy
235 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,107 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Sarah PrinslooPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
470 Total Patients Enrolled

Media Library

Duloxetine (Serotonin and Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04560673 — Phase 2
Peripheral Neuropathy Research Study Groups: Group II (neurofeedback training), Group I (neurofeedback training, duloxetine), Group III (duloxetine)
Peripheral Neuropathy Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT04560673 — Phase 2
Duloxetine (Serotonin and Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04560673 — Phase 2
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT04560673 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What findings have been made in other research projects that also looked at Duloxetine?

"Currently, 26 separate clinical trials are ongoing to research duloxetine. Out of these, 4 have reached Phase 3. Trials for duloxetine are being conducted at 786 different locations with a large concentration in Redwood City, California."

Answered by AI

What are the most popular indications for Duloxetine?

"Duloxetine is an effective medication for treating diabetic peripheral neuropathy, knee pain, and major depressive disorder."

Answered by AI

How large is the patient sample size for this clinical trial?

"That is correct, the listing on clinicaltrials.gov demonstrates that this study is still recruiting participants. The trial was first posted on 7/10/2020 and was last updated on 10/6/2022. There are plans to enroll 380 patients at 2 locations."

Answered by AI

Are researchers looking for more participants in this clinical trial?

"Yes, the information on clinicaltrials.gov point out that this study is actively recruiting patients. The study was first posted on 7/10/2020 and was last updated on 10/6/2022. The clinical trial is looking for 380 participants between 2 sites."

Answered by AI

What are some of the dangers associated with taking Duloxetine?

"Duloxetine, for which this is a Phase 2 trial meaning that while there is some safety data it has yet to be proven effective, received a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Numbness and pain due to body injuries.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How is medicine administered and is there pay for study?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
2020. "Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04560673.
All > Neuropathy > Peripheral Neuropathy
~117 spots leftby Dec 2025
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