Lung Carcinoma
Conditions
Brief summary
This clinical trial investigates the effects of switching from smoking regular cigarettes to electronic cigarettes (e-cigarettes) among older adult smokers at high risk for lung cancer. E-cigarettes use heated vapor to deliver nicotine. Information gained from this trial may help inform regulators of the potential risks and benefits of switching smokers at high risk for lung cancer to electronic cigarettes. This research also may help inform the Food and Drug Administration (FDA) how best to regulate e-cigarettes with the goal of improving public health.
Detailed description
PRIMARY OBJECTIVE: I. To characterize the effects of switching from combustible cigarettes (CCs) to e-cigarettes (ECs) on product use, product acceptability, and reinforcement among adult daily CC smokers at high risk for lung cancer. EXPLORATORY OBJECTIVES: I. To characterize the effects of switching from CCs to ECs on biomarkers of inflammation and oxidative stress among adult daily CC smokers at high for lung cancer. II. To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer III. To characterize which factors moderate or mediate the effects of switching from CCs to ECs among CC smokers at high risk for lung cancer OUTLINE: Participants are assigned to switch to e-cigarettes. Participants vape study-provided e-cigarettes for 26 weeks. Participants use smartphone to answer questions about nicotine cravings and mood and log daily smoking activity every day for up to 26 weeks. Participants complete questionnaires over 30-45 minutes and undergo collection of urine and blood samples on study.
Interventions
Vape e-cigarettes
Sponsors
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 50-80 years who currently smokes at least 1 or more combustible cigarettes per day OR who is a nondaily smoker (any self-reported smoking in the past 30 days) with a 20 pack-year history. * Being interested in trying ECs to change CC smoking behavior * Willing to have biospecimen samples taken, either in-home using a mobile phlebotomoty service, or at an approved collection site * Have an address where he/she can receive mail * Being fluent in spoken and written English * Agrees to comply with all MD Anderson institutional policies related to COVID-19 screening prior to any in-person research visit. * The individual agrees to not engage in study procedures or interactions with study personnel while operating a vehicle.
Exclusion criteria
* Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9 * Have ever had a diagnosis of lung cancer, have uncontrolled or unstable medical condition (e.g., uncontrolled hypertension, angina, diabetes) * Unwilling to consent for blood draw * Evidence of cognitive deficits or instability that would preclude reliable study participation * Being pregnant, engaging in breast-feeding, or being of childbearing potential and engaging in sexual activity that could lead to pregnancy and is not protected by a medically acceptable, effective method of birth control while enrolled in the study, as determined by self-report. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use. * Considered by the investigator to be an unsuitable or unstable candidate (including but not limited to the following situations: unwilling or unable to comply with study procedures) * Individuals who reside in an area that is outside of our shipping company or mobile phlebotomty contractors' areas of operation or in a jurisdiction outside of our medical staff's licensure (if unable to attend in-person clinic visits) AND who decline to come in to clinic to provide necessary samples and/or collect study products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combustible Cigarettes Per Day | Study Week 1 and Week 27 | Mean cigarettes per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Electronic Cigarette Sessions Per Day | Study Week 27 | Mean electronic cigarette sessions per day during the week of baseline combustible cigarette smoking and during the final week of electronic cigarette provision (week 27) |
| Anabasine | Study Week 1 and Week 27 | Geometric means of the natural log of urine anabasine levels collected at study week 1 (end of combustible cigarette smoking baseline) and week 27 (end of electronic cigarette provision). |
| Fagerström Test for Cigarette Dependence | Study Week 1 and Week 27 | The Fagerström Test for Cigarette Dependence (FTCD) is a measure of cigarette dependence. Scores range from 0 to 10, with higher scores indicating greater dependence. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJason Robinson, PHD
M.D. Anderson Cancer Center
Participant flow
Recruitment details
Participants were adults residing in the state of Texas
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.51 years STANDARD_DEVIATION 5.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 36 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 87 Participants |
| Region of Enrollment United States | 135 participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 135 |
| other Total, other adverse events | 79 / 135 |
| serious Total, serious adverse events | 7 / 135 |
Outcome results
None listed