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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135326
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 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 : October 10, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


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 Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Procedure: Transcranial Direct Current Stimulation
Undergo tDCS
Other Name: tDCS




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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).

  5. Incidence of adverse events [ Time Frame: Up to 4-6 weeks post-treatment ]
    Frequency counts and percentages will be documented.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135326


Contacts
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Contact: Salahadin Abdi 713-745-7246 sabdi@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Salahadin Abdi    713-745-7246      
Principal Investigator: Salahadin Abdi         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Salahadin Abdi M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04135326    
Other Study ID Numbers: 2018-0541
NCI-2019-03834 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0541 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019

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