Clinical trial NCT05412875: Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
Official title: A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Lung Non-Small Cell Carcinoma
Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage I Lung Cancer AJCC v8
Stage IA1 Lung Cancer AJCC v8
Stage IA2 Lung Cancer AJCC v8
Stage IA3 Lung Cancer AJCC v8
Stage IB Lung Cancer AJCC v8
Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8
Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IIIC Lung Cancer AJCC v8
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial investigates the acceptability of electronic cigarettes (JUUL) for smoking cessation (quitting smoking) and the reduction of surgery-related complications in patients with newly diagnosed head, neck, or lung cancer. Smoking before surgery is associated with increased risk of complications during and after surgery. Electronic cigarettes are a type of special product that gives small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking. Stopping cigarette smoking before surgery may reduce the risk of complications during and after surgery in patients with head, neck, or lung cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate feasibility, acceptability, compliance, and safety of a non-randomized 2-month trial of a pod based electronic cigarette (intervention) versus usual care for stage I-III lung cancer patients and stage I-IV head and neck cancer patients undergoing surgical resection.

II. Examine the effect of the pod based electronic cigarette (intervention) on surgical complications, quality of life, and whether it promotes complete or incomplete switching to the non-combustible product.

OUTLINE: Patients choose to participate in 1 of 2 arms.

ARM I: Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods.

ARM II: Patients receive usual care.

After completion of study intervention, patients are followed up at 2 and 6 months.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed lung cancer subjects will be stages I-III non-small cell lung cancer (NSCLC) and head and neck cancer subjects will be stages I-IV squamous cell carcinoma (SCC).
* Current smokers of combustible cigarettes who smoke \>= 4 days/week.
* Lung cancer patients planning to undergo wedge resection surgery for their index cancer.
* Head and neck cancer patients planning to undergo surgical resection of their index cancer or exploratory biopsies (tonsil cancer).
* Patients must intend to receive ongoing oncology care at Ohio State University \[OSU\] (i.e., their clinic visit is not a consultation/second opinion).
* Patients that are over the age of 21 years.

Exclusion Criteria:

* Patients who are cognitively unable to understand the consent form or participate in interviews.
* Patients with hearing impairments.
* Patients who are planning to use or are currently using cessation medication to help quit or reduce smoking.
* Patients who are currently using e-cigarettes.
* Patients undergoing surgery including lobectomy, pneumonectomy, tracheotomy, laryngectomy, or free flap surgery.
* Patients with contraindications to per oral intake.
* Lung cancer patients who are on home supplemental oxygen at baseline.
* Patients that have problems with dexterity that would impact electronic cigarette use.
* Patients under 21 years of age.
* Patients who don't speak and read English.
* Patients with histologies other than NSCLC, or squamous cell carcinoma of the head and neck.
* Patients with nasopharyngeal, thyroid, or gland cancers.
* Patients with inoperable tumors.
* Pregnant women.
* Prisoners.

Primary outcomes:
measure: Feasibility of patients measured by number of screened per month
timeFrame: Up to 6 months
measure: Feasibility of patients measured by number of screened per month by eligibility status
timeFrame: Up to 6 months
measure: Feasibility of patients measured by number of screened per month by refusal status
timeFrame: Up to 6 months
measure: Reasons for participant ineligibility
timeFrame: Baseline
measure: Reasons for participant refusal
timeFrame: Baseline
measure: Acceptance measured by participation rate
timeFrame: Up to 6 months
measure: Compliance
timeFrame: Up to 6 months
measure: Adherence
timeFrame: Baseline and hospital admission for surgery
measure: Incidence of adverse events (AEs)
timeFrame: Up to 14 days after delivery of intervention
measure: Complication rate (primary preliminary efficacy)
timeFrame: Up to 6 months
measure: Quality of life (QOL) - anxiety & depression
timeFrame: Up to 6 months
measure: Quality of life (QOL) - anxiety & depression 2
timeFrame: Up to 6 months
measure: Quality of life (QOL) - Perceptions of cancer
timeFrame: Up to 6 months
measure: Quality of life (QOL) - Health outcomes
timeFrame: Up to 6 months
measure: Quality of life (QOL) - Health outcomes 2
timeFrame: Up to 6 months
measure: 7 day point prevalence of tobacco use
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Theodore Brasky, PhD
role: PRINCIPAL_INVESTIGATOR
References: