Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transcranial Direct Current Stimulation (tDCS) to Reduce Pain in Patients With Chemotherapy Induced Peripheral Neuropathy: A Pilot Study

Conditions
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Chemotherapy-Induced Peripheral Neuropathy, Malignant Neoplasm

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Procedure: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion: Age greater than or equal to 18 years. Able to give a Voluntary written consent. Cancer patients with chemotherapy induced peripheral neuropathy of at least 3 months duration.. Pain and/or tingling of at least 4/10 Exclusion: History of seizure History of migraine headache History of brain cancer and/or brain metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (tDCS)<br>Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Transcranial Direct Current Stimulation<br>* Undergo tDCS<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |