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

Primary Purpose

Nicotine Dependence, Other Tobacco Product, Bladder Cancer, Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

HALO

About this trial

This is an interventional other trial for Nicotine Dependence, Other Tobacco Product

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Dartmouth Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

HALO G6

HALO Triton

Arm Description

HALO cigalike model

HALO tank model

Outcomes

Primary Outcome Measures

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.

Average Number of E-cigarettes Used Per Day

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02648178

First Posted

January 5, 2016

Last Updated

September 18, 2019

Sponsor

Dartmouth-Hitchcock Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02648178

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2016 (Actual)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The aim of the study is to determine the appeal of e-cigarettes compared to combustible cigarettes as measured by the degree to which patients succeed in reducing their cigarette consumption over the 9 weeks they are supplied with product, along with their consumption of e-cigarettes. We will measure past use of e-cigarettes and cigarettes at baseline, 3, 6, 9, and 12 weeks. We will also assess the effect of e-cigarette substitution on toxicity by measuring expired carbon monoxide and urine NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) , a carcinogenic metabolite of cigarette smoke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HALO G6

Arm Type

Active Comparator

Arm Description

HALO cigalike model

Arm Title

HALO Triton

Arm Type

Active Comparator

Arm Description

HALO tank model

Intervention Type

Device

Intervention Name(s)

HALO

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 Weeks

Title

Average Number of E-cigarettes Used Per Day

Description

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

Time Frame

12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James D Sargent, MD

Organizational Affiliation

Dartmouth College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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