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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-03834 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0541 | Other Identifier | M D Anderson Cancer Center |
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Per PI termination request, no patients enrolled
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This early phase I trial studies how well transcranial direct current stimulation works in reducing pain in cancer patients with chemotherapy induced peripheral neuropathy. Transcranial direct current stimulation is used for patients with brain injuries such as strokes as well as for mental health issues such as depression and may help to control pain in cancer patients with chemotherapy induced peripheral neuropathy.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing chemotherapy induced painful peripheral neuropathy (CIPPN).
Ia. Evaluate the change in pain scores Ib. Assess for changes in other symptoms (i.e insomnia, feeling of well-being, depression and anxiety).
SECONDARY OBJECTIVES:
I. To evaluate the following with the treatment of tDCS:
Ia. Assess for changes in using pain medications. Ib. Assess for changes in functioning (daily activities). Ic. Assess for changes in quality of life. Id. Assess for changes in neuropathy. Ie. Assess overall satisfaction with the tDCS treatment.
TERTIARY OBJECTIVES:
I. To evaluate tDCS treatment related side-effects.
OUTLINE:
Patients undergo tDCS once daily (QD) over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
After completion of study treatment, patients are followed up weekly for 3 weeks and at 4-6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (tDCS) | Experimental | Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality-of-Life Assessment | Other | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in chemotherapy induced peripheral neuropathy pain score | The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst). | Baseline up to final day of treatment (3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total opioid requirement (morphine equivalent daily dosage) | Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs. | Baseline up to 4-6 weeks post-treatment |
| Change in cancer related symptoms |
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Inclusion:
Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Salahadin Abdi | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2019 | Oct 7, 2024 |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Transcranial Direct Current Stimulation | Procedure | Undergo tDCS |
|
|
We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst). |
| Baseline up to 4-6 weeks post-treatment |
| Change in functioning of Daily Activities | We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst). | Baseline up to 4-6 weeks post-treatment |
| Change in quality of life questionnaire | We will analyze each patient's Pain Management Center Follow-Up/ Progress Notes and Standardize questionnaire which includes the assessment of the aforementioned symptoms on a 11-point numeric rating scales (0=none to 10=worst). | Baseline up to 4-6 weeks post-treatment |
| Incidence of adverse events | Frequency counts and percentages will be documented. | Up to 4-6 weeks post-treatment |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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