Using duloxetine and neurofeedback to treat nerve pain from chemotherapy
Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
This study is testing whether combining a medication called duloxetine with brain training can help people with nerve pain from chemotherapy feel better compared to using either treatment alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT04560673 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of combining duloxetine, a medication that helps relieve nerve pain and depression, with neurofeedback training, a therapy that teaches patients to control their brain waves, in treating chemotherapy-induced peripheral neuropathy (CIPN). Patients will be randomized into three groups: one receiving both duloxetine and neurofeedback, one receiving only neurofeedback, and one receiving only duloxetine. The study aims to determine if the combination treatment is more effective than either treatment alone and to identify the optimal number of neurofeedback sessions needed for long-term relief. Participants will be followed up at 6 and 12 months to assess improvements in symptoms and quality of life.
Who should consider this trial
Good fit: Ideal candidates are cancer survivors experiencing chemotherapy-induced peripheral neuropathy with a pain score of 4 or higher.
Not a fit: Patients currently undergoing chemotherapy or those with neuropathic symptoms not related to chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of nerve pain in cancer survivors, enhancing their quality of life.
How similar studies have performed: While the combination of duloxetine and neurofeedback is a novel approach, previous studies have shown success with each treatment individually in managing neuropathic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have the ability to understand and read English, sign a written informed consent, and be willing to follow protocol requirements * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * 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 * Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician) * Patients must have had neuropathic symptoms for a minimum of 3 months * No plans to change pain medication regimen during the course of the study * Off active chemotherapy treatment for minimum of 3 months * 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 * Willing to come to one of the participating cancer centers for the therapy sessions; or willing to participate in the therapy sessions at their homes and live within a 45 minute drive of the main campuses; or can participate in the therapy sessions from MD Anderson regional care centers * If participants agree to the Remote Training Option, participants should be willing to receive equipment at their homes and to return the equipment to MDA in case of malfunction or completion of the study * 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: * Patients who are taking any antipsychotic medications * 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 * Patients with known, previously diagnosed peripheral neuropathy from causes other than chemotherapy * Patients who have a history of head injury or who have known seizure activity * Patients for whom any contraindications of DL are known * Patients with suicidal ideation * Patients who are already taking duloxetine for peripheral neuropathy
Where this trial is running
Houston, Texas and 1 other locations
- Harris Health System (LBJ) — Houston, Texas, United States (Recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Prinsloo — M.D. Anderson Cancer Center
- Study coordinator: Sarah Prinsloo
- Email: sprinsloo@mdanderson.org
- Phone: 713-563-9627
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.