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

M.D. Anderson Cancer Center

Status and phase: Withdrawn; Early Phase 1

Conditions: Malignant Neoplasm; Chemotherapy-Induced Peripheral Neuropathy

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04135326

NCI-2019-03834 (Registry Identifier)

2018-0541 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (tDCS)

Experimental group

Description:

Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Procedure: Transcranial Direct Current Stimulation