Clinical trial NCT03219502: rTMS in Improving Neuropathy in Patients With Stage I-IV Cancer Who Have Received Oxaliplatin Chemotherapy
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) to Treat Oxaliplatin-Induced Neuropathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Neoplasm
Neuropathy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-07-17
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in perceptions of chemotherapy-induced peripheral neuropathy (CIPN)
timeFrame: Baseline up to 1 month
Secondary outcomes:
measure: Change in cortical activity
timeFrame: Baseline up to 1 month
measure: Change in perception of improvement in CIPN as assessed by Patients' Global Impression of Change (PGIC) questionnaire
timeFrame: Baseline up to 1 month
measure: Change in perception of improvement in CIPN as assessed by Edmonton Symptom Assessment System (ESAS) questionnaire
timeFrame: Baseline up to 1 month
measure: Change in perception of improvement in CIPN as assessed by Brief Pain Inventory-short form (BPI) questionnaire
timeFrame: Baseline up to 1 month
measure: Change in perception of improvement in CIPN as assessed by Pain Vigilance and Awareness Questionnaire (PVAQ)
timeFrame: Baseline up to 1 month
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Sarah Prinsloo
role: PRINCIPAL_INVESTIGATOR
References: