Smoking Cessation Prior to Surgery to Reduce Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-000868
    • Mankato, Minnesota: 17-000868
    • La Crosse, Wisconsin: 17-000868
    NCT ID: NCT02856581
    Sponsor Protocol Number: A211401

About this study

This randomized phase III trial studies how well smoking cessation intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. This study will use two smoking cessation interventions: Varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) with behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with the same behavioral interventions. It is not yet known whether smoking cessation intervention prior to surgery is effective in reducing surgical complications for these patients.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

  1. Eligible patients will have a new diagnosis of lung cancer and have sought a surgical consult relating to this diagnosis.
  2. Surgery must be scheduled no sooner than 10 days after randomization and no more than twelve weeks after randomization.
  3. Have smoked daily or nearly every day in the previous 6 months up to the date of surgical consult AND have smoked at least one puff in the previous 7 days.
  4. Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation Ladder as defined in the protocol.
  5. Within the 30 days before registration, no use of: 1) any pharmacologic treatment for smoking cessation, including buproprion or nicotine replacement therapy; 2) any nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in any formal behavioral treatment program for tobacco dependence as determined by patient report.
  6. No allergies to and not currently using varenicline.
  7. No suicidal thoughts as indicated by a positive (1+) response to question 9 on the PHQ9.
  8. No active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression).
  9. Negative pregnancy test (serum or urine) done ≤7 days prior to registration, for women of childbearing potential only. A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  10. No unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia.
  11. No history of seizures.
  12. No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic disease.
  13. Not currently on renal dialysis or has a history of significant renal impairment
  14. No recent history (≤ 90 days) of substance abuse (outside of tobacco) defined by NIAAA as:
  • If male, drinking >14 alcoholic beverages per week for past 1 month.
  • If female, drinking >7 alcoholic beverages per week for past 1 month.
  • Use of cocaine, heroin, club drugs (i.e., MDMA/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past
  • 1 month.
  • Use of marijuana on a weekly basis for the past 1 month.

    15. Patients must be able to complete study questionnaires in English.

    16. ≥18 years of age

    17. No other household member or relative participating in the study.

    18. No known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence.

    19.Calculated creatinine clearance ≥ 30 mL/min

  • Creatinine clearance (CrCl) will be calculated using the Cockroft-Gault equation as follows: CrCI (ml/min) = (140-age) x actual wt (in kg) / 72 x serum creatinine (mg/dL)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Francis Nichols, M.D.

Contact us for the latest status

Contact information:

Karlyn Pierson R.N., CCRP

(507)538-1960

Pierson.Karlyn@mayo.edu

Mankato, Minn.

Mayo Clinic principal investigator

Francis Nichols, M.D.

Contact us for the latest status

Contact information:

Judy Westphal R.N.

La Crosse, Wis.

Mayo Clinic principal investigator

Francis Nichols, M.D.

Open for enrollment

Contact information:

Deborah Schultz R.N.

(608)392-6810

Schultz.Deborah1@mayo.edu

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20313162

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