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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04135326
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-Induced Peripheral Neuropathy; Malignant Neoplasm	Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Transcranial Direct Current Stimulation	Early Phase 1

Detailed Description

PRIMARY OBJECTIVES:

1. 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:

1. 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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Transcranial Direct Current Stimulation (tDCS) to Reduce Pain in Patients With Chemotherapy Induced Peripheral Neuropathy: A Pilot Study
• Actual Study Start Date: Oct 10, 2019
• Actual Primary Completion Date: Oct 26, 2020
• Actual Study Completion Date: Oct 26, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in chemotherapy induced peripheral neuropathy pain score [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).

Secondary Outcome Measures

1. Change in total opioid requirement (morphine equivalent daily dosage) [Baseline up to 4-6 weeks post-treatment]

   Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs.

2. Change in cancer related symptoms [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).

3. Change in functioning of Daily Activities [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).

4. Change in quality of life questionnaire [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).

5. Incidence of adverse events [Up to 4-6 weeks post-treatment]

   Frequency counts and percentages will be documented.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center
• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Texas MD Anderson Cancer Center Website

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT04135326
• Other Study ID Numbers: 2018-0541; NCI-2019-03834; 2018-0541
• First Posted: Oct 22, 2019
• Last Update Posted: Nov 13, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Peripheral Nervous System Diseases

Study Results

No Results Posted as of Nov 13, 2020