Clinical trial NCT05144542: Risk and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
Official title: The Potential Risks and Benefits of Electronic Cigarettes to Older Smokers at High Risk for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-12-03
Enrollment: 140
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

SECONDARY OBJECTIVE:

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.

EXPLORATORY OBJECTIVES:

I. To characterize metabolomic changes that result from switching from CCs to ECs among CC smokers at high risk for lung cancer.

II. To character 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cigarettes per day
timeFrame: Up to 182 days
Secondary outcomes:
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: through study completion, an average of 1 year
measure: White blood cells (WBC)
timeFrame: through study completion, an average of 1 year
measure: 8-epi prostaglandin F2 alpha (8-epi-PGF2a)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jason Robinson, PHD
role: PRINCIPAL_INVESTIGATOR
References: