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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04135326
• Other study ID #: 2018-0541
• Secondary ID: NCI-2019-0383420
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: October 10, 2019
• Est. completion date: October 26, 2020

Study information

• Verified date: November 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Peripheral Neuropathy
• Malignant Neoplasm
• Neoplasms
• Peripheral Nervous System Diseases

Intervention

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Transcranial Direct Current Stimulation
Undergo tDCS

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   University of Texas MD Anderson Cancer Center Website