Smoking cessation and relapse prevention represent and important opportunity to improve cancer survival rates, reduce the risk of cancer treatment complication, and improve the quality of life of patients with and survivors of cancer. Previous studies showed that repetitive TMS (rTMS) reduced cue craving to smoking and treat nicotine dependent smokers. Recently one study completed by our team demonstrated that 10 sessions of rTMS over the left dorsolateral prefrontal cortex (DLPFC) reduced cigarette consumption and cue craving, and also increased quitting rate on target quit date in nicotine dependent smokers. Thus, we propose conducting a controlled, double-blind trial comparing the effect of treatments of active rTMS and sham rTMS on cigarette abstinence days, cigarette consumption and smoking craving during a 7-days of quit attempt period in 20 nicotine-dependent patients with cancer. Specific aims are: Aim 1: Assess a feasibility of the rTMS for smoking cessation in cancer patients. Aim 2: Obtain preliminary estimates of whether one-week active rTMS of left 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.
Specific aims: Smoking cessation and relapse prevention represent and important opportunity to improve cancer survival rates , reduce the risk of cancer treatment complication, and improve the quality of life of patients with and survivors of cancer . Previous studies showed that repetitive TMS (rTMS) reduced cue craving to smoking and treat nicotine dependent smokers. Recently one study completed by our team demonstrated that 10 sessions of rTMS over the left dorsolateral prefrontal cortex (DLPFC) reduced cigarette consumption and cue craving, and also increased quitting rate on target quit date in nicotine dependent smokers. Thus, we propose conducting a controlled, double-blind trial comparing the effect of treatments of active rTMS and sham rTMS on cigarette abstinence days, cigarette consumption and smoking craving during a 7-days of quit attempt period in 20 nicotine-dependent patients with cancer. Specific aims are: Aim 1: Assess a feasibility of the rTMS for smoking cessation in cancer patients. Aim 2: Obtain preliminary estimates of whether one-week active rTMS of left 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. 1.1. Primary objective To assess a feasibility of the rTMS for smoking cessation in cancer patients: The primary feasibility measures are : whether or not we can enroll 20 cancer patients with smoking within 12 months? 1.2 Secondary objectives (1) Study attrition. How many subjects can complete 7-day quit attempt during rTMS treatment? How many subjects will complete one-month follow-up? (2) To obtain preliminary estimates of whether one-week active rTMS of left 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. 1.3 Exploratory objectives Self-reported number of cigarettes smoked per day, The brief questionnaire of smoking urges (QSU - Brief), visual analog scale for craving and side effect will be measured pre and post each rTMS session. Other assessment, Carbon Monoxide, Fagerstrom Test for Nicotine Dependence (FTND), and Minnesota Nicotine withdrawing Scale (MNWS) will be completed at baseline and the last TMS. Quitting attempt will verify daily CO \< 5 ppm. FTND, Feasibility metrics will also be tracked, including numbers of complete TMS sessions and dropout rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
Medical University of South Carolina
Charleston, South Carolina, United States
The Number of Enrollment
How many cancer patients with smoking can be enrolled in 12 months?
Time frame: 12 months
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days.
Total number of smoke-free days during a day quit attempt. Self-reported abstinence during the day quit attempt will be assessed via timeline. The maximum number of consecutive days of abstinence will be recorded. Participants who does not report at least one 24-hour period of abstinence will be recorded as "0" days abstinent.
Time frame: 5 days
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