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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06553 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0712 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (neurofeedback training, duloxetine) | Experimental | 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. |
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| Group II (neurofeedback training) | Experimental | Patients receive neurofeedback training over 1 hour 3-5 times weekly for up to 5 weeks. |
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| Group III (duloxetine) | Experimental | Patients receive duloxetine PO QD for 5 weeks in the absence of unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Given PO |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Prinsloo | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harris Health System (LBJ) | Houston | Texas | 77026 | United States | ||
| M D Anderson Cancer Center |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Neurofeedback | Behavioral | Receive neurofeedback training |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline 5 up to week 10 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Houston |
| Texas |
| 77030 |
| United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |
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