Brain Stimulation For Cancer Smokers

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.

Inclusion Criteria:

- 1. Completed cancer treatment (e.g. surgery, chemotherapy and radiation) > 6 months
Patients with current endocrine therapy will be included for the study.

2. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer
or prostate cancer.

3. Smoke 5 or more cigarettes per day and have a carbon monoxide (CO) level > 5 ppm
indicative of recent smoking.

4. Not have received substance abuse treatment within the previous 30 days. 5. Meet
criteria for low to moderate nicotine dependence as determined by FTND ≥1.

6. Be willing to provide informed consent. 7. Be able to comply with protocol
requirements and likely to complete all study procedures.

8. Is willing to consider trying to quit smoking. 9. Have no active cardiac,
neurologic, or psychiatric illness. 10. 0.5-10 years post diagnosis of cancer at the
time enrollment.

Exclusion Criteria:

1. Current dependence, defined by Diagnostic and Statistical manual of Mental Disorders
(DSM)-V criteria, on any psychoactive substances other than nicotine or caffeine.

2. 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).

3. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.

4. History of neurological disorder that would lead to local or diffuse brain lesions or
significant physical impairment.