This trial studies how repetitive transcranial magnetic stimulation works in increasing abstinence and decreasing cigarette consumption in patients with stage I-IIIA cancer. Repetitive transcranial magnetic stimulation uses magnetic pulses to temporarily stimulate specific areas of the brain. Using how repetitive transcranial magnetic stimulation may promote smoking cessation in cancer patients who smoke.
Additional locations may be listed on ClinicalTrials.gov for NCT03419741.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess a feasibility of the repetitive transcranial magnetic stimulation (rTMS) for smoking cessation in cancer patients.
SECONDARY OBJECTIVES:
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.
EXPLORATORY OBJECTIVES:
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 PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
Principal InvestigatorLi Xingbao