Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer... | NCT05412875

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

NCT05412875

Sponsor

Ohio State University Comprehensive Cancer Center

Status

Withdrawn

Last Update Posted

Apr 12, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

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

Interventions

Best Practice
Nicotine Replacement
Quality-of-Life Assessment
Questionnaire Administration

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
NCI-2022-00864	Registry Identifier	CTRP (Clinical Trial Reporting Program)
K07CA215546	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding lapse

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

May 17, 2022

First Submission Date that Met QC Criteria

Jun 7, 2022

First Posted Date

Jun 9, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2024

Last Update Posted Date

Apr 12, 2024Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

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

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Best Practice	Other	Given usual care	Arm II (usual care)	standard of care

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck
D002289	Carcinoma, Non-Small-Cell Lung
D008175	Lung Neoplasms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D017410	Practice Guidelines as Topic
D059039	Standard of Care
D000095488	Nicotine Replacement Therapy

ID	Term
D017408	Guidelines as Topic
D011785	Quality Assurance, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation
D019984	Quality Indicators, Health Care
D004358	Drug Therapy
D013812	Therapeutics