Repetitive Transcranial Magnetic Stimulation in Promoting Smoking Cessation in Patients with Stage I-IIIA Cancer

Status: Active

Description

This trial studies how repetitive transcranial magnetic stimulation works in increasing abstinence and decreasing cigarette consumption in patients with stage I-IIIA cancer. Repetitive transcranial magnetic stimulation uses magnetic pulses to temporarily stimulate specific areas of the brain. Using how repetitive transcranial magnetic stimulation may promote smoking cessation in cancer patients who smoke.

Eligibility Criteria

Inclusion Criteria

  • 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) lung cancer, head and neck cancer, 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.
  • Meet criteria for low to moderate nicotine dependence as determined by the FTND >= 1.
  • Be willing to provide informed consent.
  • Be able to comply with protocol requirements and likely to complete all study procedures.
  • Is willing to consider trying to quit smoking.
  • Have no active cardiac, neurologic, or psychiatric illness.
  • 1 week - 10 years post diagnosis of cancer at the time enrollment.

Exclusion Criteria

  • Current dependence, defined by Diagnostic and Statistical Manual of Mental Disorders - 5 (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.

Locations & Contacts

South Carolina

Charleston
Medical University of South Carolina
Status: Active
Contact: Li Xingbao
Phone: 843-792-5729
Email: lixi@musc.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess a feasibility of the repetitive transcranial magnetic stimulation (rTMS) for smoking cessation in cancer patients.

SECONDARY OBJECTIVES:

I. To obtain preliminary estimates of whether one-week active rTMS of left dorsolateral prefrontal cortex (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.

EXPLORATORY OBJECTIVES:

I. Self-reported number of cigarettes smoked per day, cue-induced craving (Questionnaire of Smoking Urges [QSU] – Brief), visual analog scale for craving and side effect will be measured pre and post each rTMS session.

II. Other assessment, Carbon Monoxide, Fagerstrom Test for Nicotine Dependence (FTND), and Minnesota Nicotine Withdrawal Scale (MNWS-R) will be completed at baseline and the last transcranial magnetic stimulation (TMS).

III. FTND, Feasibility metrics will also be tracked, including numbers of complete TMS sessions and dropout rate.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (ACTIVE rTMS): Within a 7-day quit attempt from smoking, patients undergo rTMS daily over 15 minutes for 5 sessions. Patients begin quit attempt after first session.

ARM II (SHAM rTMS): Within a 7-day quit attempt from smoking, patients undergo sham rTMS daily over 15 minutes for 5 sessions. Patients begin quit attempt after first session.

After completion of study, patients will be followed up for 1 month.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Prevention

Lead Organization

Lead Organization
Medical University of South Carolina

Principal Investigator
Li Xingbao

Trial IDs

Primary ID 102743
Secondary IDs NCI-2018-01882, Pro00066330
Clinicaltrials.gov ID NCT03419741