Brain Stimulation For Cancer Smokers

Breast Cancer Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation For Smoking Cessation In Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419741
• Other study ID #: Pro00066330
• Status: Completed
• Phase: N/A
• Start date: October 21, 2017
• Est. completion date: October 20, 2020

Study information

• Verified date: April 2022
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Cancer of Head and Neck
• Head and Neck Neoplasms
• Nicotine Dependence
• Prostate Cancer
• Tobacco Use Disorder

Intervention

Device:
• Transcranial Magnetic Stimulation Clinical Research System
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Effect of rTMS on Cigarette Consumption	the change of self-reported number of cigarettes smoked per day	5 days
Other	Effect of rTMS on Cue Craving to Smoke Cigarette	Brief questionnaire of smoking urges - brief (QSU - Brief) is used to assess smoking urges. Ten questions are included in the test. Range of scales is 1-7 score for each item. The cue craving scales include 10 items. The range of the total score is 10- 70 score. The maximum number means the highest craving that is the worst outcome. The minimum number is the least craving for cigarettes that is the best outcome.	5 days
Other	Effect of rTMS on Cue Craving to Smoke Cigarette	The change of visual analog scale (VAS). The VAS has 1-7 score. The minimum is 1 which means the best result. The maximum value of 7 is the worst outcome. The VAS was measured during 5 treatment sessions.	5 days
Other	Adverse Events	Side effect will be measured pre and post each rTMS session.	5 days
Other	Study Attrition Rate	How many subjects completed treatment and a 30 days follow-up.	12 months
Primary	The Number of Enrollment	How many cancer patients with smoking can be enrolled in 12 months?	12 months
Secondary	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.	5 days