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

NCT05412875 | Withdrawn DMC FDA Device

• 3 other identifiers: OSU-21255NCI-2022-00864K07CA215546
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (2)

Arm I (JUUL)

EXPERIMENTAL

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.

Drug: Nicotine Replacement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (usual care)

ACTIVE COMPARATOR

Patients receive usual care.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Given usual care

Also known as: standard of care, standard therapy

Arm II (usual care)

Nicotine Replacement DRUG

Given JUUL

Also known as: Nicotine Replacement Therapy, NRT

Arm I (JUUL)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (JUUL); Arm II (usual care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (JUUL); Arm II (usual care)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

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

Interventions

Practice Guidelines as Topic; Standard of Care; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Drug Therapy; Therapeutics

Study Officials

• Theodore Brasky, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 9, 2022
• Study Start: January 1, 2024
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)