Breast Cancer, Cancer of Head and Neck, Nicotine Dependence, Prostate Cancer
Conditions
Keywords
Cancer, Nicotine Addiction, Smoking Cessation
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.
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.
Interventions
DEVICETranscranial 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Sham TMS
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Enrollment | 12 months | How many cancer patients with smoking can be enrolled in 12 months? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effect of rTMS on Cigarette Consumption | 5 days | the change of self-reported number of cigarettes smoked per day |
| Effect of rTMS on Cue Craving to Smoke Cigarette | 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. |
| Adverse Events | 5 days | Side effect will be measured pre and post each rTMS session. |
| Study Attrition Rate | 12 months | How many subjects completed treatment and a 30 days follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 5 |
| 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.
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. | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Active rTMS Treatment | Sham rTMS Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 63.25 years | 64.5 years | 63.9 years |
| Cigarette per day = the number of smoked cigarettes per 24 hours | 15 cigarettes | 10 cigarettes | 13 cigarettes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 6 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 1 / 4 | 0 / 4 |
| serious Total, serious adverse events | 1 / 4 | 0 / 4 |
Outcome results
Primary
The Number of Enrollment
How many cancer patients with smoking can be enrolled in 12 months?
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active rTMS Treatment | The Number of Enrollment | 4 participants |
| Sham rTMS Treatment | The Number of Enrollment | 4 participants |
percentage
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.
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active rTMS Treatment | Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days. | 0 days |
| Sham rTMS Treatment | Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on the Number of Abstinence Days. | 0 days |
Other Pre-specified
Adverse Events
Side effect will be measured pre and post each rTMS session.
Time frame: 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active rTMS Treatment | Adverse Events | 2 number of events |
| Sham rTMS Treatment | Adverse Events | 0 number of events |
Other Pre-specified
Effect of rTMS on Cigarette Consumption
the change of self-reported number of cigarettes smoked per day
Time frame: 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active rTMS Treatment | Effect of rTMS on Cigarette Consumption | 12.17 number of cigarettes | Standard Error 1.48 |
| Sham rTMS Treatment | Effect of rTMS on Cigarette Consumption | 11.29 number of cigarettes | Standard Error 1.71 |
Other Pre-specified
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.
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 1 | 45.3 score on a scale | Standard Deviation 24.9 |
| Active rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 5 | 25.6 score on a scale | Standard Deviation 24.1 |
| Sham rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 1 | 36.0 score on a scale | Standard Deviation 43.7 |
| Sham rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 5 | 32.8 score on a scale | Standard Deviation 44.7 |
Other Pre-specified
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.
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 1 | 5.2 score on a scale | Standard Deviation 2.1 |
| Active rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 5 | 3.7 score on a scale | Standard Deviation 3.2 |
| Sham rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 1 | 3.8 score on a scale | Standard Deviation 2.9 |
| Sham rTMS Treatment | Effect of rTMS on Cue Craving to Smoke Cigarette | Session 5 | 3.5 score on a scale | Standard Deviation 3.1 |
Other Pre-specified
Study Attrition Rate
How many subjects completed treatment and a 30 days follow-up.
Time frame: 12 months
Population: One dropped out of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Active rTMS Treatment | Study Attrition Rate | 1 participants |
| Sham rTMS Treatment | Study Attrition Rate | 0 participants |