Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02093 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2016-1134 | Other Identifier | M D Anderson Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (rTMS) | Experimental | Patients undergo rTMS over 30 minutes for 10 sessions over 10 business days. |
|
| Group II (sham rTMS) | Sham Comparator | Patients undergo sham rTMS over 30 minutes for 10 sessions over 10 business days. |
|
| Group III (standard of care) | Active Comparator | Patients receive standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard of care |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah Prinsloo | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Repetitive Transcranial Magnetic Stimulation | Procedure | Undergo rTMS |
|
|
| Sham Intervention | Procedure | Undergo sham rTMS |
|
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
Not provided
Not provided