Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Malignant Solid Neoplasm Clinical Trial

Official title:

Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04560673
• Other study ID #: 2019-0712
• Secondary ID: NCI-2020-0655320
• Status: Recruiting
• Phase: Phase 2
• Start date: July 10, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: M.D. Anderson Cancer Center
• Contact: Sarah Prinsloo
• Phone: 713-563-9627
• Email: sprinsloo[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial investigates how well duloxetine and neurofeedback training work in treating patients with chemotherapy induced peripheral neuropathy. Duloxetine is a type of serotonin and norepinephrine reuptake inhibitor that increases the amount of certain chemicals in the brain that help relieve depression and peripheral neuropathy. Neurofeedback training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity and may help teach patients with peripheral neuropathy (nerve damage) how to change their own brain waves to lower their feelings of neuropathy and help improve their overall quality of life. Giving duloxetine and neurofeedback training may work better in treating peripheral neuropathy caused by chemotherapy compared to duloxetine or neurofeedback training alone.

Description:

PRIMARY OBJECTIVE:

I. Determine if the combination of duloxetine (DL) and neurofeedback (NFB) is superior to DL or NFB alone in treating chemotherapy induced peripheral neuropathy (CIPN).

SECONDARY OBJECTIVES:

I. Determine the optimal number of neurofeedback sessions needed to result in long-term relief of CIPN in a large cohort of cancer survivors and across socioeconomic groups.

II. Examine baseline brain signatures as a predictor of response to neurofeedback (NFB) and to duloxetine and determine who will require more sessions of NFB to achieve relief of symptoms.

III. Examine if the combination of DL + NFB (than those getting DL or NFB alone) or a larger number of NFB sessions results in better improvements in cancer-related symptoms, physical functioning, and quality of life (QOL).

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients receive neurofeedback training over 1 hour each 3-5 times weekly for up to 5 weeks. Patients also receive duloxetine orally (PO) once daily (QD) for 5 weeks in the absence of unacceptable toxicity.

GROUP II: Patients receive neurofeedback training session over 1 hour 3-5 times weekly for up to 5 weeks.

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

After completion of study, patients are followed up at 6 and 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Peripheral Nervous System Diseases

Intervention

Drug:
• Duloxetine
Given PO

Behavioral:
• Neurofeedback
Receive neurofeedback training

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Harris Health System (LBJ)	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Quality Assessment Scale (PQAS) unpleasantness score	The primary analysis will be a linear model comparing the mean difference in the change of the unpleasantness subscale of the (PQAS)Pain Quality Assessment Scale from baseline to the end of treatment (5 weeks) between the combination arm, the duloxetine (DL), and the neurofeedback (NFB) arm while adjusting for the stratification factor. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.	Baseline 5 up to week 10
Secondary	Change in PQAS unpleasantness score	Will use analysis of covariance (ANCOVA) to evaluate whether chemotherapy induced peripheral neuropathy (CIPN) differs across the three subgroups with 0, 10 or 15 additional sessions of NFB, among the participants from the NFB + DL group who report at least 1-point clinical improvement in CIPN at week 5. The analysis will adjust for the baseline outcome (at week 5), time with CIPN symptoms (minimization factor), and other covariates such as age, sex, cancer stage, time since diagnosis, and cancer type, as appropriate. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.	Baseline 5 up to week 10
Secondary	Baseline brain signatures as predictors of response to NFB and to DL	Will perform ANCOVA with the change of the unpleasantness subscale from baseline to week 5 (i.e., end of the first 15 sessions of NFB) as the outcome, intervention (NFB, DL or combo), the brain signature (one at a time) and its interaction with intervention as the independent variables of interest. Pain Quality Assessment Scale (0-10) 0-No pain-10 Most Intense Pain Imaginable.	Up to week 5
Secondary	Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms	Linear mixed model (LMM) analyses will be performed using data measured at end of treatment, months 6 and 12 only on patients who report clinical improvement at week 5.	Up to 12 months post-treatment
Secondary	Change in cancer-related symptoms	ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms.	Baseline up to 12 months post-treatment
Secondary	Change in physical functioning	ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning.	Baseline up to 12 months post-treatment
Secondary	Change in quality of life	ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life.	Baseline up to 12 months post-treatment

External Links

•   M D Anderson Cancer Center