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

Early Phase 1

Withdrawn

Interventions: Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Procedure: Transcranial Direct Current Stimulation

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Supportive care (tDCS)	Questionnaire Administration	Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
Supportive care (tDCS)	Quality-of-Life Assessment	Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
Supportive care (tDCS)	Transcranial Direct Current Stimulation	Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.

Primary Outcome Measures

Name	Time	Method
Change in chemotherapy induced peripheral neuropathy pain score	Baseline up to final day of treatment (3 weeks)	The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).

Secondary Outcome Measures

Name	Time	Method
Change in total opioid requirement (morphine equivalent daily dosage)	Baseline up to 4-6 weeks post-treatment	Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs.
Change in cancer related symptoms	Baseline up to 4-6 weeks post-treatment	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).
Change in functioning of Daily Activities	Baseline up to 4-6 weeks post-treatment	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).
Change in quality of life questionnaire	Baseline up to 4-6 weeks post-treatment	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).
Incidence of adverse events	Up to 4-6 weeks post-treatment	Frequency counts and percentages will be documented.