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

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ClinicalTrials.gov Identifier: NCT04560673
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Peripheral Neuropathy Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Drug: Duloxetine Behavioral: Neurofeedback Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
Actual Study Start Date : July 10, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (neurofeedback training, duloxetine)
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.
Drug: Duloxetine
Given PO

Behavioral: Neurofeedback
Receive neurofeedback training
Other Name: EEG biofeedback

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (neurofeedback training)
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
Behavioral: Neurofeedback
Receive neurofeedback training
Other Name: EEG biofeedback

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Group III (duloxetine)
Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
Drug: Duloxetine
Given PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Change in Pain Quality Assessment Scale (PQAS) unpleasantness score [ Time Frame: Baseline 5 up to week 10 ]
    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.


Secondary Outcome Measures :
  1. Change in PQAS unpleasantness score [ Time Frame: Baseline 5 up to week 10 ]
    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.

  2. Baseline brain signatures as predictors of response to NFB and to DL [ Time Frame: Up to week 5 ]
    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.

  3. Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms [ Time Frame: Up to 12 months post-treatment ]
    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.

  4. Change in cancer-related symptoms [ Time Frame: Baseline up to 12 months post-treatment ]
    ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms.

  5. Change in physical functioning [ Time Frame: Baseline up to 12 months post-treatment ]
    ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning.

  6. Change in quality of life [ Time Frame: Baseline up to 12 months post-treatment ]
    ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560673


Contacts
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Contact: Sarah Prinsloo 713-563-9627 sprinsloo@mdanderson.org

Locations
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United States, Texas
Harris Health System (LBJ) Recruiting
Houston, Texas, United States, 77026
Contact: HILARY Y. MA    713-792-4171      
Principal Investigator: HILARY Y. MA         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarah Prinsloo    713-563-9627      
Principal Investigator: Sarah Prinsloo         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sarah Prinsloo M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04560673    
Other Study ID Numbers: 2019-0712
NCI-2020-06553 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0712 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents