Clinical trial NCT03419741: Brain Stimulation For Cancer Smokers
Official title: Repetitive Transcranial Magnetic Stimulation For Smoking Cessation In Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Head and Neck
Breast Cancer
Prostate Cancer
Nicotine Dependence
Keywords: Cancer, Nicotine Addiction, Smoking Cessation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, double-blinded design of active rTMS and sham rTMS. The pilot will include a total of 20 nicotine-dependent patients with cancer. Subjects will be randomized to either sham rTMS or real rTMS over the left DLPFC. At the end of 7-day study, everyone can be referred to the Hollings Cancer Center (HCC) Tobacco Treatment Program for active treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Number of Enrollment
timeFrame: 12 months
Secondary outcomes:
measure: Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days.
timeFrame: 5 days
Other outcomes:
measure: Effect of rTMS on Cigarette Consumption
timeFrame: 5 days
measure: Effect of rTMS on Cue Craving to Smoke Cigarette
timeFrame: 5 days
measure: Effect of rTMS on Cue Craving to Smoke Cigarette
timeFrame: 5 days
measure: Adverse Events
timeFrame: 5 days
measure: Study Attrition Rate
timeFrame: 12 months
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: Li X, Hartwell KJ, Owens M, Lematty T, Borckardt JJ, Hanlon CA, Brady KT, George MS. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Biol Psychiatry. 2013 Apr 15;73(8):714-20. doi: 10.1016/j.biopsych.2013.01.003. Epub 2013 Feb 26.