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

Primary Purpose

Chemotherapy-Induced Peripheral Neuropathy, Malignant Neoplasm

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Quality-of-Life Assessment
Questionnaire Administration
Transcranial Direct Current Stimulation
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-Induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (tDCS)

Arm Description

Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change in total opioid requirement (morphine equivalent daily dosage)
Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs.
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).
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).
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).
Incidence of adverse events
Frequency counts and percentages will be documented.

Full Information

First Posted
October 10, 2019
Last Updated
November 11, 2020
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04135326
Brief Title
Transcranial Direct Current Stimulation in Reducing Pain in Cancer Patients With Chemotherapy Induced Peripheral Neuropathy
Official Title
Transcranial Direct Current Stimulation (tDCS) to Reduce Pain in Patients With Chemotherapy Induced Peripheral Neuropathy: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Per PI termination request, no patients enrolled
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Peripheral Neuropathy, Malignant Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (tDCS)
Arm Type
Experimental
Arm Description
Patients undergo tDCS QD over 20 minutes 5 days each week (Monday-Friday) for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Undergo tDCS
Primary Outcome Measure Information:
Title
Change in chemotherapy induced peripheral neuropathy pain score
Description
The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst).
Time Frame
Baseline up to final day of treatment (3 weeks)
Secondary Outcome Measure Information:
Title
Change in total opioid requirement (morphine equivalent daily dosage)
Description
Will be summarized using descriptive statistics including mean, standard deviation, median, range, and CIs.
Time Frame
Baseline up to 4-6 weeks post-treatment
Title
Change in cancer related symptoms
Description
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).
Time Frame
Baseline up to 4-6 weeks post-treatment
Title
Change in functioning of Daily Activities
Description
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).
Time Frame
Baseline up to 4-6 weeks post-treatment
Title
Change in quality of life questionnaire
Description
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).
Time Frame
Baseline up to 4-6 weeks post-treatment
Title
Incidence of adverse events
Description
Frequency counts and percentages will be documented.
Time Frame
Up to 4-6 weeks post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salahadin Abdi
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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