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Brain Stimulation For Cancer Smokers

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ClinicalTrials.gov Identifier: NCT03419741
Recruitment Status : Recruiting
First Posted : February 2, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Cancer of Head and Neck Breast Cancer Prostate Cancer Nicotine Dependence Device: Transcranial Magnetic Stimulation Clinical Research System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Sham TMS
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation For Smoking Cessation In Cancer Patients
Actual Study Start Date : October 21, 2017
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active rTMS treatment
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
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.

Sham Comparator: Sham rTMS treatment
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
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.




Primary Outcome Measures :
  1. The number of enrollment [ Time Frame: 12 months ]
    How many cancer patients with smoking can be enrolled in 12 months?


Secondary Outcome Measures :
  1. Effect of repetitive transcranial magnetic stimulation (rTMS) on the 7-day quit rate [ Time Frame: 30 days ]
    Total number of smoke-free days during a 7-day quit attempt. Self-reported abstinence during the 7-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.


Other Outcome Measures:
  1. Effect of rTMS on cigarette consumption [ Time Frame: 30 days ]
    self-reported number of cigarettes smoked per day

  2. Effect of rTMS on cue craving to smoke cigarette [ Time Frame: 30 days ]
    Brief questionnaire of smoking urges - brief (QSU - Brief)

  3. Effect of rTMS on cue craving to smoke cigarette [ Time Frame: 7 days ]
    Visual analog scale (VAS) for craving (1-7)

  4. Adverse Events [ Time Frame: 7 days ]
    Side effect will be measured pre and post each rTMS session.

  5. Study attrition rate [ Time Frame: 12 months ]
    How many subjects can complete 7-day quit attempt during rTMS treatment? How many subjects will complete one-month follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419741


Contacts
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Contact: Xingbao Li, M.D 843 792-5729 lixi@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Xingbao Li, M.D    843-792-5729    lixi@musc.edu   
Principal Investigator: Xingbao Li, M.D         
Sponsors and Collaborators
Medical University of South Carolina

Publications:
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03419741     History of Changes
Other Study ID Numbers: Pro00066330
First Posted: February 2, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Medical University of South Carolina:
Cancer, Nicotine Addiction, Smoking Cessation

Additional relevant MeSH terms:
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Tobacco Use Disorder
Head and Neck Neoplasms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neoplasms by Site
Neoplasms