Repetitive Transcranial Magnetic Stimulation in Promoting Smoking Cessation in Patients with Stage I-IIIA Cancer
- Completed cancer treatment (e.g. surgery, chemotherapy and radiation) > 6 months. Patients with current endocrine therapy will be included for the study.
- Have been diagnosed with noninvasive or invasive (stage 1, 2, or 3A) lung cancer, head and neck cancer, breast cancer or prostate cancer.
- Smoke 5 or more cigarettes per day and have a carbon monoxide (CO) level > 5 ppm indicative of recent smoking.
- Not have received substance abuse treatment within the previous 30 days.
- Meet criteria for low to moderate nicotine dependence as determined by the FTND >= 1.
- Be willing to provide informed consent.
- Be able to comply with protocol requirements and likely to complete all study procedures.
- Is willing to consider trying to quit smoking.
- Have no active cardiac, neurologic, or psychiatric illness.
- 1 week - 10 years post diagnosis of cancer at the time enrollment.
- Current dependence, defined by Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-V) criteria, on any psychoactive substances other than nicotine or caffeine.
- Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy).
- History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
- History of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
I. To assess a feasibility of the repetitive transcranial magnetic stimulation (rTMS) for smoking cessation in cancer patients.
I. To obtain preliminary estimates of whether one-week active rTMS of left dorsolateral prefrontal cortex (DLPFC) tends to be more efficacious than sham rTMS during a 7-days of quit attempt laboratory model period increasing abstinence days, and also decreasing cigarette consumption and cue-elicited craving in cancer patients with smoking.
I. Self-reported number of cigarettes smoked per day, cue-induced craving (Questionnaire of Smoking Urges [QSU] – Brief), visual analog scale for craving and side effect will be measured pre and post each rTMS session.
II. Other assessment, Carbon Monoxide, Fagerstrom Test for Nicotine Dependence (FTND), and Minnesota Nicotine Withdrawal Scale (MNWS-R) will be completed at baseline and the last transcranial magnetic stimulation (TMS).
III. FTND, Feasibility metrics will also be tracked, including numbers of complete TMS sessions and dropout rate.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I (ACTIVE rTMS): Within a 7-day quit attempt from smoking, patients undergo rTMS daily over 15 minutes for 5 sessions. Patients begin quit attempt after first session.
ARM II (SHAM rTMS): Within a 7-day quit attempt from smoking, patients undergo sham rTMS daily over 15 minutes for 5 sessions. Patients begin quit attempt after first session.
After completion of study, patients will be followed up for 1 month.
Trial Phase Phase NA
Trial Type Prevention
Medical University of South Carolina
- Primary ID 102743
- Secondary IDs NCI-2018-01882, Pro00066330
- Clinicaltrials.gov ID NCT03419741