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Brain Stimulation For Cancer Smokers

20 april 2022 uppdaterad av: Medical University of South Carolina

Repetitive Transcranial Magnetic Stimulation For Smoking Cessation In Cancer Patients

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

11

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29425
        • Medical University of South Carolina

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Enhet: 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.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The Number of Enrollment
Tidsram: 12 months
How many cancer patients with smoking can be enrolled in 12 months?
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days.
Tidsram: 5 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effect of rTMS on Cigarette Consumption
Tidsram: 5 days
the change of self-reported number of cigarettes smoked per day
5 days
Effect of rTMS on Cue Craving to Smoke Cigarette
Tidsram: 5 days
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
Effect of rTMS on Cue Craving to Smoke Cigarette
Tidsram: 5 days
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
Adverse Events
Tidsram: 5 days
Side effect will be measured pre and post each rTMS session.
5 days
Study Attrition Rate
Tidsram: 12 months
How many subjects completed treatment and a 30 days follow-up.
12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medical University of South Carolina

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 oktober 2017

Primärt slutförande (Faktisk)

20 oktober 2020

Avslutad studie (Faktisk)

20 oktober 2020

Studieregistreringsdatum

Först inskickad

2 januari 2018

Först inskickad som uppfyllde QC-kriterierna

26 januari 2018

Första postat (Faktisk)

5 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 april 2022

Senast verifierad

1 april 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Pro00066330

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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