Study Stopped
Per PI termination request, no patients enrolled
Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2019
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedStudy Start
First participant enrolled
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2020
CompletedOctober 9, 2024
November 1, 2020
1 year
October 10, 2019
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Change in total opioid requirement (morphine equivalent daily dosage)
Baseline up to 4-6 weeks post-treatment
Change in cancer related symptoms
Baseline up to 4-6 weeks post-treatment
Change in functioning of Daily Activities
Baseline up to 4-6 weeks post-treatment
Change in quality of life questionnaire
Baseline up to 4-6 weeks post-treatment
Incidence of adverse events
Up to 4-6 weeks post-treatment
Study Arms (1)
Supportive care (tDCS)
EXPERIMENTALPatients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
Interventions
Ancillary studies
Undergo tDCS
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of seizure
- History of migraine headache
- History of brain cancer and/or brain metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Salahadin Abdi
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 22, 2019
Study Start
October 10, 2019
Primary Completion
October 26, 2020
Study Completion
October 26, 2020
Last Updated
October 9, 2024
Record last verified: 2020-11