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

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


  • Org Study ID: D15154
  • Secondary ID:
  • NCT ID: NCT02648178
  • NCT Alias:
  • Sponsor: Dartmouth-Hitchcock Medical Center - Other
  • Source: Dartmouth-Hitchcock Medical Center

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, a carcinogenic metabolite of cigarette
smoke.

Overal Status Start Date Phase Study Type
Recruiting Start Date: June 2016 N/A Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Participant Use of E-Cigarettes

Primary Outcome 1 - Time Frame: 12 Weeks

Condition:

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

Eligibility

Criteria:
Inclusion Criteria:

1. Histological or cytological diagnosis of lung, head & neck, or bladder cancer within
the past 5 years.

2. AJCC stages I-IV

3. Daily Smoking (at least 10 cigarettes per day for 10 years) and breath CO greater than
or equal to 9 ppm

4. Does not wish to quit smoking now (anyone wishing to quit smoking will be referred for
smoking cessation counselling through the DHMC program)

5. May be receiving anti-cancer agents

6. Age 18 or older

7. Fluent in English;

8. Patient must be capable and willing to provide informed written consent for study
participation;

9. Able to participate in study visits

Exclusion Criteria:

1. Cancer surgery planned in the next 9 weeks;

2. Treatment with radiation planned for the next 9 weeks,

3. 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.)

4. Any use of e-cigarettes in the past 30 days,

5. Pregnant or trying to get pregnant.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: James D Sargent, MD

Role: Principal Investigator

Affiliation: Dartmouth College

Overall Contact

Name: Tanya M Perry, BS, CCRP

Phone: 603-650-6056

Email: tanya.m.perry@hitchcock.org

Location

Facility Status Contact
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
United States
Recruiting Tanya M Perry, BS, CCRP
603-650-6056
tanya.m.perry@hitchcock.org