Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Smoking Cessation Clinical Trial

— TTOP  

Official title:

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634071
• Other study ID #: MCC-20-MULTI-34
• Status: Recruiting
• Phase: Phase 2
• Start date: January 12, 2021
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: University of Kentucky
• Contact: Joseph Valentino, MD
• Phone: 859-257-5097
• Email: jvale00[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.

Description:

Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.

Study Design Phase II therapeutic clinical trial.

Setting University of Kentucky Markey Cancer Center (MCC) and its affiliate research network of Community Cancer Centers (MCCRN)

Methods Ninety-three subjects will be selected. All subjects will be active smoking oncology patients with a diagnosis of smoking related malignancy who are beginning a new course of therapy. In conjunction with their treating clinician, all subjects will be counseled and then select one of 12 cessation strategies. This will include a choice of continuous pharmacologic agent (veranicline, bupropion or transdermal nicotine patch), counseling strategy (11 session high intensity motivational based counseling or single session low intensity counseling), and whether or not to use as needed nicotine (gum, lozenges or spray).

Data Analysis All subjects will be followed for six months. The primary endpoint will be a carbon monoxide monitoring confirmed negative seven-day point prevalence report of cessation at eight weeks. Data will then be analyzed and compared with a completed randomized clinical trial of the same treatment strategies in the same population of subjects where the cessation strategy was assigned (historical control). The proportion of subjects that have quit at week eight will be compared to the historical control proportion (namely, whether Ho:p=po vs Ha: p>po). This will be assessed using a z-score for a binomial proportion which will test whether the underlying proportion quitting at eight weeks (p) differs from the control proportion (po ranging from 0.215 to 0.26) estimated from our recently completed randomized trial of these same 12 cessation strategies.

Revised Enrollment Number: Effective with Amendment 2, Expand targeted enrollment from 96 to 126 due to higher than expected drop-out/censoring rate in order to evaluate the primary endpoint

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• newly diagnosed or recurrent tobacco related malignancy

• smoked at least 1 cigarette within 4 weeks of study enrollment

• 10-pack year history of cigarette smoking

• smoked at least 1 cigarette within 1 month of cancer diagnosis

• life expectancy greater than 1 year

Exclusion Criteria:

• allergy to buproprion, varenicline and transdermal medicine

• history of suicide attempt

• hospitalized for psychiatric illness within past 2 years

• history of active or uncontrolled eating disorder

• uncontrolled epilepsy or seizure disorder

• pregnant or lactating

• within 3 months of myocardial infarction

• unstable angina

• uncontrolled hypertension

• serious arrhythmia

• history of taking varenicline or buproprion within one month of enrollment

• concurrent enrollment in tobacco cessation therapy

Related Conditions & MeSH terms

• Cancer, Treatment-Related
• Neoplasms, Second Primary
• Smoking Cessation

Intervention

Drug:
• Varenicline
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
• Bupropion
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
• Long-acting nicotine replacement therapy
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.

Behavioral:
• Low-intensity counseling
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
• High-intensity counseling
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.

Other:
• No nicotine replacement therapy
Participants in this group will not receive per required need nicotine replacement therapy.

Drug:
• Nicotine Replacement Products
Participants in this group will receive per required need nicotine replacement therapy.

Locations

Country	Name	City	State
United States	Kings Daughters Medical Center - Ashland	Ashland	Kentucky
United States	Med Center Health	Bowling Green	Kentucky
United States	University Of Kentucky, Markey Cancer Center	Lexington	Kentucky
United States	Owensboro Health Mitchell Memorial Cancer Center	Owensboro	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Joseph Valentino, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients requiring financial assistance with medication.	Number of patients requiring financial assistance with medication.	6 months
Other	Number of patients with alteration in therapy	Number of patients with alteration in therapy due to ongoing cancer treatment.	6 months
Other	Insurance coverage	Proportion of treatments covered by insurance/third party.	6 months
Primary	Proportion of participants that quit smoking.	Proportion of participants that quit smoking at the 8 week assessment	at week 8
Primary	Prevalence of cigarette use	Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.	at week 8
Secondary	Prevalence of cigarette use	Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.	6 months
Secondary	Preferred treatment	Proportion of participants preferring the treatment plan.	at baseline
Secondary	Change in Cigarette Use	Cigarette use will be recorded at weeks one, four, eight and at 6 months.	6 months
Secondary	Drug Compliance	Subjects who complete 75% of the planned dosages of therapy will be considered compliant.	6 months
Secondary	Counselling Compliance	Subjects who complete 60% of planned therapy sessions will be considered compliant.	6 months