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

Primary Purpose

Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Duloxetine
Neurofeedback
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-Induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harris Health System (LBJ)Recruiting
  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group I (neurofeedback training, duloxetine)

Group II (neurofeedback training)

Group III (duloxetine)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
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.
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.
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.
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.

Full Information

First Posted
September 11, 2020
Last Updated
September 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04560673
Brief Title
Duloxetine and Neurofeedback Training for the Treatment of Chemotherapy Induced Peripheral Neuropathy
Official Title
Optimizing Neurofeedback to Treat Chemotherapy Induced Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2020 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (neurofeedback training, duloxetine)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (neurofeedback training)
Arm Type
Experimental
Arm Description
Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks.
Arm Title
Group III (duloxetine)
Arm Type
Experimental
Arm Description
Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
Given PO
Intervention Type
Behavioral
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
EEG biofeedback
Intervention Description
Receive neurofeedback training
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Pain Quality Assessment Scale (PQAS) unpleasantness score
Description
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.
Time Frame
Baseline 5 up to week 10
Secondary Outcome Measure Information:
Title
Change in PQAS unpleasantness score
Description
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.
Time Frame
Baseline 5 up to week 10
Title
Baseline brain signatures as predictors of response to NFB and to DL
Description
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.
Time Frame
Up to week 5
Title
Evaluation of patients who will require more sessions of NFB to achieve relief of symptoms
Description
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.
Time Frame
Up to 12 months post-treatment
Title
Change in cancer-related symptoms
Description
ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on cancer-related symptoms.
Time Frame
Baseline up to 12 months post-treatment
Title
Change in physical functioning
Description
ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on physical functioning.
Time Frame
Baseline up to 12 months post-treatment
Title
Change in quality of life
Description
ANCOVA and LMM analyses will be performed to evaluate the effect of the number of additional NFB sessions on quality of life.
Time Frame
Baseline up to 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Prinsloo
Phone
713-563-9627
Email
sprinsloo@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Prinsloo
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harris Health System (LBJ)
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HILARY Y. MA
Phone
713-792-4171
First Name & Middle Initial & Last Name & Degree
HILARY Y. MA
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Prinsloo
Phone
713-563-9627
First Name & Middle Initial & Last Name & Degree
Sarah Prinsloo

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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