Brain Stimulation For Cancer Smokers

NCT03419741 | Completed Results FDA Device

• 1 other identifier: Pro00066330
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck; Breast Cancer; Prostate Cancer; Nicotine Dependence

Keywords

Cancer, Nicotine Addiction, Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• The Number of Enrollment

  How many cancer patients with smoking can be enrolled in 12 months?

  12 months

Secondary Outcomes (1)

• Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days.

  5 days

Other Outcomes (5)

• Effect of rTMS on Cigarette Consumption

  5 days

• Effect of rTMS on Cue Craving to Smoke Cigarette

  5 days

• Effect of rTMS on Cue Craving to Smoke Cigarette

  5 days

Study Arms (2)

Active rTMS treatment

ACTIVE COMPARATOR

Transcranial Magnetic Stimulation Clinical Research System will be used for the active rTMS treatment. Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% resting motor threshold, Total 60 trains, 15 minutes, Total pulses 3000 per day, 3000 x 5 = 15000 pulses for 5 sessions.

Device: Transcranial Magnetic Stimulation Clinical Research System

Sham rTMS treatment

SHAM COMPARATOR

Transcranial Magnetic Stimulation Clinical Research System -sham TMS will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.

Device: Transcranial Magnetic Stimulation Clinical Research System

Interventions

Transcranial Magnetic Stimulation Clinical Research System DEVICE

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.

Active rTMS treatment; Sham rTMS treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Completed cancer treatment (e.g. surgery, chemotherapy and radiation) \> 6 months Patients with current endocrine therapy will be included for the study.
• \. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer or prostate cancer.
• \. Smoke 5 or more cigarettes per day and have a carbon monoxide (CO) level \> 5 ppm indicative of recent smoking.
• \. 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.
• \. Be willing to provide informed consent. 7. Be able to comply with protocol requirements and likely to complete all study procedures.
• \. 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.

You may not qualify if:

• Current dependence, defined by Diagnostic and Statistical manual of Mental Disorders (DSM)-V criteria, on any psychoactive substances other than nicotine or caffeine.
• 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).
• History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
• History of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related 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.

  PMID: 23485014 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Tobacco Use Disorder; Neoplasms; Smoking Cessation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Xingbao Li
• Organization: Medical University of SouthCarolina

lixi@musc.edu

843 7925729

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham TMS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: February 5, 2018
• Study Start: October 21, 2017
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: May 13, 2022
• Results First Posted: May 13, 2022

Record last verified: 2022-04

Locations

US (1)