Evaluation of Appeal and Impact of E-Cigarettes Among Chronic Smokers With Smoking-Related Cancers

NCT02648178 | Completed Results DMC

• 1 other identifier: D15154
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test feasibility, in smokers with lung, head \& neck, and bladder cancers, that examines the effect of e-cigarette substitution, on measures of smoking-related toxicity and medical outcomes. The aim of the study is to determine the appeal of e-cigarettes compared to regular combustible cigarettes.

Conditions

Nicotine Dependence, Other Tobacco Product; Bladder Cancer; Lung Cancer; Cancer of Head and Neck

Outcome Measures

Primary Outcomes (2)

• Change in Daily Cigarette Smoking Given 10 or More E-cigarette Sessions in a Day

  Participants report of daily cigarette and e-cigarette use for the previous 7 days at each study time-point (baseline and 3, 6, 9, and 12 weeks post-baseline) will be averaged to create usual daily cigarette. Mixed-effects linear regression with a random effect at the participant level will be used to assess the association between usual cigarette use (dependent variable) and usually e-cigarette use (independent predictor) over the study period while accounting for the repeated measures within subject. The model will be fit using restricted maximum likelihood. Time will be included in the model as continuous and categorical, separately, and we assess for stability of the association between cigarette use and e-cigarette over time by including an interaction term between e-cigarette use and time in the model.

  12 Weeks

• Average Number of E-cigarettes Used Per Day

  Average number of e-cigarettes used per day over the 12 week period

  12 Weeks

Study Arms (2)

HALO G6

ACTIVE COMPARATOR

HALO cigalike model

Device: HALO

HALO Triton

ACTIVE COMPARATOR

HALO tank model

Device: HALO

Interventions

HALO DEVICE

HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.

HALO G6; HALO Triton

Eligibility Criteria

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

You may qualify if:

• Histological or cytological diagnosis of lung, head \& neck, or bladder cancer within the past 5 years.
• AJCC (American Joint Committee on Cancer) stages I-IV
• Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO (carbon monoxide) greater than or equal to 9 ppm
• Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for smoking cessation counselling through the DHMC (Dartmouth Hitchcock Medical Center) program)
• May be receiving anti-cancer agents
• Age 18 or older
• Fluent in English;
• Patient must be capable and willing to provide informed written consent for study participation;
• Able to participate in study visits

You may not qualify if:

• Cancer surgery planned in the next 9 weeks;
• Treatment with radiation planned for the next 9 weeks,
• Actively trying to quit smoking, or planning to in the next 30 days. (If a subject reports that they plan to quit smoking in the next 30 days, we will call them after the 30 days to see if they are still trying to quit.)
• Any use of e-cigarettes in the past 30 days,
• Pregnant or trying to get pregnant.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Urinary Bladder Neoplasms; Lung Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr James Sargent
• Organization: The Koop Institute at Dartmouth, Geisel School of Medicine

James.D.Sargent@dartmouth.edu

603-653-9025

Study Officials

• James D Sargent, MD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Oncology

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 6, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 19, 2019
• Results First Posted: September 19, 2019

Record last verified: 2019-09

Locations

US (1)