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).
Female subjects aged ≥ 18 years.
Histologically confirmed breast or gynecologic cancer.
Platinum-based drugs
Taxanes
Evidence of recurrent breast or gynecologic cancer at the time of enrollment.
Current or planned treatment with chemotherapy.
History of seizure, epilepsy, or other conditions that would, in the opinion of the investigator, negatively impact the patient's safety or ability to participate in the study.
Presence of neuropathic pain unrelated to systemic cancer therapy, including but not limited to: painful diabetic neuropathy, HIV-induced neuropathy, neuropathic pain from radiation therapy and underlying cancer/other medical conditions.
Single group
rTMS
DeviceRepetitive Transcranial Magnetic Stimulation will be administered Monday-Friday for two weeks (10 sessions total)
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.
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%.
To evaluate the safety of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
The rTMS therapy will be feasible if at least 70% of the treated subjects can complete at least 70% of the treatment sessions.
To evaluate the feasibility of 10 sessions of open-label 10-Hz rTMS of the motor cortex in individuals with CIPN.
Change in Pain Numeric Rating Scale (PNRS)
To evaluate the duration of pain (0- no pain to 10-worst pain imaginable) relief after treatment with rTMS.
Change in Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29) v.2.1
To evaluate the change in patient-reported outcomes. Each question usually has five response options ranging in value from one to five. The raw score is the sum of the values of the response to each question. From the raw score, the T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. This outcome measure will report the mean T-scores of 8 subscales; Physical Function (Range: 22.5-57), Anxiety (40.3-81.6), Depression (41.0-79.4), Fatigue (33.7-75.8), Sleep Disturbance (32-73.3), Social Roles (27.5-64.2), Pain Interference (41.6-75.6), and Cognitive Function (29.5-61.2).
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