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

October 7, 2024 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in chemotherapy induced peripheral neuropathy pain score
Time Frame: 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).
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)
Time Frame: Baseline up to 4-6 weeks post-treatment
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
Time Frame: 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).
Baseline up to 4-6 weeks post-treatment
Change in functioning of Daily Activities
Time Frame: 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).
Baseline up to 4-6 weeks post-treatment
Change in quality of life questionnaire
Time Frame: 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).
Baseline up to 4-6 weeks post-treatment
Incidence of adverse events
Time Frame: Up to 4-6 weeks post-treatment
Frequency counts and percentages will be documented.
Up to 4-6 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Salahadin Abdi, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Actual)

October 26, 2020

Study Completion (Actual)

October 26, 2020

Study Registration Dates

First Submitted

October 10, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0541 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-03834 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe