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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05412875
• Other study ID #: OSU-21255
• Secondary ID: NCI-2022-00864K0
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 31, 2024

Study information

• Verified date: April 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Lung Neoplasms
• Lung Non-Small Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• 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 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

Intervention

Other:
• Best Practice
Given usual care

Drug:
• Nicotine Replacement
Given JUUL

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Reasons for participant ineligibility	We will record reasons for patient ineligibility	Baseline
Primary	Reasons for participant refusal	We will record reasons for patient refusal to participate	Baseline
Primary	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
Primary	Compliance	Will be self-reported and include counting of used JUUL pods on follow-ups interviews.	Up to 6 months
Primary	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
Primary	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
Primary	Complication rate (primary preliminary efficacy)	Will be measured as the number of complications reported, per person month of follow up.	Up to 6 months
Primary	Quality of life (QOL) - anxiety & depression	Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)	Up to 6 months
Primary	Quality of life (QOL) - anxiety & depression 2	Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)	Up to 6 months
Primary	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
Primary	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
Primary	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
Primary	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

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