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

A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Squamous Cell Carcinoma; Lung Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer 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 IIIC Lung Cancer AJCC v8; Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8; Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Drug: Nicotine Replacement; Other: Best Practice

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm II (usual care); Patients receive usual care.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Given usual care; Other Names: standard of care; standard therapy
Experimental: 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Ancillary studies; Drug: Nicotine Replacement; Given JUUL; Other Names: Nicotine Replacement Therapy; NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of patients measured by number of screened per month	Will be measured by the number of screened patients per month.	Up to 6 months
Feasibility of patients measured by number of screened per month by eligibility status	Will be measured by the number of screened patients per month by eligibility status.	Up to 6 months
Feasibility of patients measured by number of screened per month by refusal status	Will be measured by the number of screened patients per month by refusal status.	Up to 6 months
Reasons for participant ineligibility	We will record reasons for patient ineligibility	Baseline
Reasons for participant refusal	We will record reasons for patient refusal to participate	Baseline
Acceptance measured by participation rate	Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.	Up to 6 months
Compliance	Will be self-reported and include counting of used JUUL pods on follow-ups interviews.	Up to 6 months
Adherence	Further, exhaled carbon monoxide (a marker of short-term smoking status) will be assessed at baseline and upon hospital admission for surgery.	Baseline and hospital admission for surgery
Incidence of adverse events (AEs)	Will be assessed at days 2 and 14 following the delivery of the intervention and reported by participants. Further, participants will be invited to contact the research team to report any adverse events related to the use of the intervention at any time point.	Up to 14 days after delivery of intervention
Complication rate (primary preliminary efficacy)	Will be measured as the number of complications reported, per person month of follow up.	Up to 6 months
Quality of life (QOL) - anxiety & depression	Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)	Up to 6 months
Quality of life (QOL) - anxiety & depression 2	Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)	Up to 6 months
Quality of life (QOL) - Perceptions of cancer	Self-reported QOL measures will include the Perceptions of Lung Cancer to assess views on their disease (modified slightly for head and neck cancer patients)	Up to 6 months
Quality of life (QOL) - Health outcomes	Self-reported QOL measures will include the EQ-5D-5L to assess overall and cancer-specific health outcomes (including cough, dyspnea, dysphagia, and pain).	Up to 6 months
Quality of life (QOL) - Health outcomes 2	Self-reported QOL measures will include the and EORTC-QLQ-LC13 to assess overall and cancer-specific health outcomes (including cough, dyspnes, dysphagia, and pain).	Up to 6 months
7 day point prevalence of tobacco use	7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups	Up to 6 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Theodore Brasky, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: OSU-21255; NCI-2022-00864 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); K07CA215546 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No