Nicotine Replacement for Malignant Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Malignant Neoplasms+24 More
Nicotine Replacement - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Malignant Neoplasms
  • Stage IA2 Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Head
  • Stage IIB Lung Cancer AJCC v8
  • Stage I Lung Cancer AJCC v8
  • Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
  • Stage IA1 Lung Cancer AJCC v8
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Stage IIA Lung Cancer AJCC v8
  • Stage IA3 Lung Cancer AJCC v8
  • Stage IB Lung Cancer AJCC v8

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Malignant Neoplasms

Study Objectives

16 Primary · 0 Secondary · Reporting Duration: Up to 6 months

Baseline
Reasons for participant ineligibility
Reasons for participant refusal
Baseline and hospital admission for surgery
Adherence
Day 14
Incidence of adverse events (AEs)
Up to 6 months
7 day point prevalence of tobacco use
Acceptance measured by participation rate
Compliance
Complication rate (primary preliminary efficacy)
Feasibility of patients measured by number of screened per month
Feasibility of patients measured by number of screened per month by eligibility status
Feasibility of patients measured by number of screened per month by refusal status
Quality of life (QOL) - Health outcomes
Quality of life (QOL) - Health outcomes 2
Quality of life (QOL) - Perceptions of cancer
Quality of life (QOL) - anxiety & depression
Quality of life (QOL) - anxiety & depression 2

Trial Safety

Safety Progress

1 of 3

Other trials for Malignant Neoplasms

Trial Design

2 Treatment Groups

Arm II (usual care)
1 of 2
Arm I (JUUL)
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Nicotine Replacement · No Placebo Group · N/A

Arm I (JUUL)Experimental Group · 3 Interventions: Questionnaire Administration, Nicotine Replacement, Quality-of-Life Assessment · Intervention Types: Other, Drug, Other
Arm II (usual care)ActiveComparator Group · 3 Interventions: Questionnaire Administration, Best Practice, Quality-of-Life Assessment · Intervention Types: Other, Other, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months
Closest Location: Ohio State University Comprehensive Cancer Center · Columbus, OH
Photo of Columbus 1Photo of Columbus 2Photo of Columbus 3
2011First Recorded Clinical Trial
0 TrialsResearching Malignant Neoplasms
203 CompletedClinical Trials

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
281 Previous Clinical Trials
285,778 Total Patients Enrolled
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,293,747 Total Patients Enrolled
Theodore Brasky, PhDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a newly diagnosed lung cancer or head and neck cancer.
You are currently a smoker of combustible cigarettes.
You are planning to undergo wedge resection surgery for your index cancer.
You are over the age of 21 years.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.