Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy
NCT ID: NCT04135326
Last Updated: 2024-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2019-10-10
2020-10-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (tDCS)
Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Transcranial Direct Current Stimulation
Undergo tDCS
Interventions
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Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Transcranial Direct Current Stimulation
Undergo tDCS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Salahadin Abdi
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2019-03834
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0541
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0541
Identifier Type: -
Identifier Source: org_study_id
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