Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (JUUL)

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.

Group Type EXPERIMENTAL

Nicotine Replacement

Intervention Type DRUG

Given JUUL

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm II (usual care)

Patients receive usual care.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Given usual care

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Given usual care

Intervention Type OTHER

Nicotine Replacement

Given JUUL

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Nicotine Replacement Therapy NRT Quality of Life Assessment

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No