Repetitive Transcranial Magnetic Stimulation for Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Breast and Gynecologic Cancer Survivors: A Pilot Study
Summary
The goal of this study is to evaluate the change in pain scores among patients with chemotherapy-induced peripheral neuropathy after receiving treatment with repetitive transcranial magnetic stimulation (rTMS).
Arms & interventions
- DevicerTMS
Repetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total)
Outcome measures
Primary
Change in Pain Numeric Rating Scale (PNRS) between screening and end of treatment in subjects who complete at least 7 rTMS treatments.
To assess the change in pain scores (0- no pain to 10-worst pain imaginable) after treatment with repetitive transcranial magnetic stimulation (rTMS) in patients with CIPN.
Time frame: 5 months
Secondary
The rTMS therapy will be considered safe if the proportion of subjects reporting treatment related grade 3 adverse device effects per Common Terminology Criteria for Adverse Events (CTCAE 5.0) is less than or equal to 5%.
Time frame: 2 years
The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions.
Time frame: 2 years
Change in Pain Numeric Rating Scale (PNRS)
Time frame: up to 4 weeks after initiation of study intervention
Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1
Time frame: up to 4 weeks after initiation of the study intervention
Change in Brief Pain Inventory-Short Form (BPI-SF) Scores
Time frame: up to 4-week after initiation of the study intervention
Change in Patient's Global Impression of Change (PGIC) Score
Time frame: up to 4-week after initiation of the study intervention
Change in EuroQol 5-Dimension, 5-Level (EQ-5D-5L)
Time frame: up to 4-week after initiation of the study intervention
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC-QLQ-CIPN-20)
Time frame: up to 4-week after initiation of the study intervention
Eligibility criteria
Study locations (1)
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112