rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy

Malignant Neoplasm Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Oxaliplatin-Induced Neuropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03219502
• Other study ID #: 2016-1134
• Secondary ID: NCI-2018-0209320
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 10, 2017
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies how well repetitive transcranial magnetic stimulation (rTMS) works in improving neuropathy due to oxaliplatin chemotherapy in patients with stage I-IV cancer. rTMS is designed to change brain activity by introducing small magnetic impulses to the scalp that encourage the brain to change its activity.

Description:

PRIMARY OBJECTIVES:

I. Examine the effects of the repetitive transcranial magnetic stimulation (rTMS) training program on perceptions of chemotherapy-induced peripheral neuropathy (CIPN) versus placebo (PC) and wait-list control groups (WLC).

SECONDARY OBJECTIVES:

I. Explore changes in cortical activity: Electroencephalography (EEG) brain maps (low resolution electromagnetic tomography) will be assessed over time and compared between groups.

II. Determine if rTMS improves other aspects of CIPN, quality of life (QOL), and mental health (MH) compared to PC and WLC.

III. Explore moderators/mediators of the intervention by examining the extent to which changes in EEG patterns mediate the effects of the intervention and the extent to which there are interaction effects of the intervention and each of the baseline brain regions.

OUTLINE: Patients are randomized to 1 of 3 groups.

GROUP I: Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.

GROUP II: Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.

GROUP III: Patients receive standard of care.

After completion of study, patients are followed up within 1 week and at 1 month.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with stage I-IV cancers who received oxaliplatin chemotherapy

• Understand and read English, sign a written informed consent, and be willing to follow protocol requirements

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2

• Grade 2 or higher neuropathic symptoms according to the National Cancer Institute's 4 point grading scale

• Neuropathic symptoms must be related to chemotherapy (in the opinion of the treating physician)

• Patients must have neuropathic symptoms for a minimum of 3 months

• No plans to change the type of pain medication (if a patient is on pain medication)

• Willing to come to MD Anderson for the therapy sessions

Exclusion Criteria:

• Patients who are taking any antipsychotic medications

• Patients who have evidence of brain metastases or any with any active central nervous system (CNS) disease at their time of entry into the trial

• Patients who have ever been diagnosed with bipolar disorder or schizophrenia

• Patients who have a history of head injury, focal brain lesions, or known seizure activity

• Patients who are withdrawing from drugs

• Patients with intracranial implants or a cardiac pacemaker or any device that is not considered magnetic resonance imaging (MRI) safe. Colorectal patients are sometimes prescribed Tramadol to help control the symptoms of CIPN. Tramadol does lower the seizure threshold, however these patients will be considered eligible for the study if they discontinue the drug 48 hours before the baseline and do not use it during the duration of the study

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Neuropathy

Intervention

Other:
• Best Practice
Receive standard of care
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Procedure:
• Repetitive Transcranial Magnetic Stimulation
Undergo rTMS
• Sham Intervention
Undergo sham rTMS

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 perceptions of chemotherapy-induced peripheral neuropathy (CIPN)	Differences between repetitive transcranial magnetic stimulation (rTMS) and placebo (PC) and between rTMS and wait-list control (WLC) will be assessed by Pain Quality Assessment Scale (PQAS). Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.; The Pain Quality Assessment Scale (PQAS) is a 20-item measure developed to quantify quality and intensity of neuropathic pain. It was derived from the Neuropathic Pain Scale and includes symptom descriptors common to people with neuropathic symptoms.[44] Our primary outcome will be the 'unpleasantness subscale'.	Baseline up to 1 month
Secondary	Change in cortical activity	Will include pre, interim, and post comparisons of the electroencephalography (EEG), via low resolution electromagnetic tomography (LORETA) imaging software, on an individual basis. These analyses will include global differences in cortical activation as well as site-specific dominant frequencies for each patient.	Baseline up to 1 month
Secondary	Change in perception of improvement in CIPN as assessed by Patients' Global Impression of Change (PGIC) questionnaire	Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.; The Patients' Global Impression of Change (PGIC) will measure clinically important change from the patient's perspective. Patients report symptoms on a range from "very much worse" to "very much improved".	Baseline up to 1 month
Secondary	Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire	Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.; The Edmonton Symptom Assessment System (ESAS) is a validated tool to assess 12 major symptoms (rated 0-10) that are common in cancer patients during the 24 hours preceding its administration. The symptoms assessed are pain, fatigue, nausea, depression, anxiety, drowsiness, shortness of breath, appetite, insomnia, well-being, financial distress, and spiritual distress.	Baseline up to 1 month
Secondary	Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire	Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.; The Brief Pain Inventory-short form (BPI) is a validated, widely used, questionnaire that will assess severity and impact of pain. We will prioritize assessment of the 'worst pain' subscale, and 'interference' subscale as they have been used to assess pain in other pain trials.	Baseline up to 1 month
Secondary	Change in perception of improvement in CIPN as assessed by Pain Vigilance and Awareness Questionnaire (PVAQ)	Will use data across the set of post-intervention assessment points. Will conduct two-sample t-tests, subtracting post-intervention scores from pre-intervention scores at each post-intervention time point.; The Pain Vigilance and Awareness Questionnaire (PVAQ) will assess attention to pain in terms of awareness, consciousness, vigilance, and observation of pain.	Baseline up to 1 month

External Links

•   MD Anderson Cancer Center Website