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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neuropathy; Malignant Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Best Practice; Procedure: Repetitive Transcranial Magnetic Stimulation; Procedure: Sham Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (rTMS); Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Repetitive Transcranial Magnetic Stimulation; Undergo rTMS; Other Names: rTMS
Sham Comparator: Group II (sham rTMS); Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Procedure: Sham Intervention; Undergo sham rTMS
Active Comparator: Group III (standard of care); Patients receive standard of care.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive standard of care; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sarah Prinsloo, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2017
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2016-1134 (Other Identifier: M D Anderson Cancer Center); NCI-2018-02093 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No