- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04634071
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment (TTOP)
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Joseph Valentino, MD
- Phone Number: 859-257-5097
- Email: jvale00@uky.edu
Study Locations
-
-
Kentucky
-
Ashland, Kentucky, United States, 41101
- Recruiting
- Kings Daughters Medical Center - Ashland
-
Contact:
- David Goebel, MD
- Phone Number: 606-325-2221
- Email: dgoebel@windstream.net
-
Bowling Green, Kentucky, United States, 42101
- Recruiting
- Med Center Health
-
Contact:
- Tina Berger
- Phone Number: 270-745-1036
- Email: bergt@mchealth.net
-
Lexington, Kentucky, United States, 40536
- Recruiting
- University of Kentucky, Markey Cancer Center
-
Principal Investigator:
- Joseph Valentino, MD
-
Owensboro, Kentucky, United States, 42303
- Recruiting
- Owensboro Health Mitchell Memorial Cancer Center
-
Contact:
- Vanissa Sorrels
- Phone Number: 270-691-8084
- Email: Vanissa.sorrels@owensborohealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Varenicline, Intense Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT).
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Other Names:
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.
Participants in this group will receive per required need nicotine replacement therapy.
Other Names:
|
Experimental: Group : Varenicline, Intense Counselling
Patients diagnosed with tobacco-related treatment will receive varenicline and counseling.
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Other Names:
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.
Participants in this group will not receive per required need nicotine replacement therapy.
Other Names:
|
Experimental: Group 3: Varenicline, Minimal Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT).
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Other Names:
Participants in this group will receive per required need nicotine replacement therapy.
Other Names:
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
|
Experimental: Group 4: Varenicline, Minimal Counselling
Patients diagnosed with tobacco-related treatment will receive varenicline and counseling.
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Other Names:
Participants in this group will not receive per required need nicotine replacement therapy.
Other Names:
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
|
Experimental: Group 5: Buproprion, Intense Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT).
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Participants in this group will receive per required need nicotine replacement therapy.
Other Names:
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.
Other Names:
|
Experimental: Group 6: Buproprion, Intense Counselling
Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling.
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Participants in this group will not receive per required need nicotine replacement therapy.
Other Names:
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.
Other Names:
|
Experimental: Group 7: Buproprion, Minimal Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT).
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
Participants in this group will receive per required need nicotine replacement therapy.
Other Names:
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
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.
Other Names:
|
Experimental: Group 8: Buproprion, Minimal Counselling
Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling.
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
Participants in this group will not receive per required need nicotine replacement therapy.
Other Names:
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
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.
Other Names:
|
Experimental: Group 9: Nicotine, Intense Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g.
nicotine patch), counseling, and nicotine replacement therapy (PRN NRT).
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Participants in this group will receive per required need nicotine replacement therapy.
Other Names:
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Other Names:
|
Experimental: Group 10: Nicotine, Intense Counselling
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g.
nicotine patch) and counseling.
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
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.
Participants in this group will not receive per required need nicotine replacement therapy.
Other Names:
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Other Names:
|
Experimental: Group 11: Nicotine, Minimal Counselling and NRT
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g.
nicotine patch), counseling, and nicotine replacement therapy (PRN NRT).
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
Participants in this group will receive per required need nicotine replacement therapy.
Other Names:
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Other Names:
|
Experimental: Group 12: Nicotine, Minimal Counselling
Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g.
nicotine patch) and counseling.
Dose and frequency will be based on patient preference, smoking history and other medical factors.
|
Participants in this group will not receive per required need nicotine replacement therapy.
Other Names:
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants that quit smoking.
Time Frame: at week 8
|
Proportion of participants that quit smoking at the 8 week assessment
|
at week 8
|
Prevalence of cigarette use
Time Frame: at week 8
|
Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
|
at week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of cigarette use
Time Frame: 6 months
|
Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
|
6 months
|
Preferred treatment
Time Frame: at baseline
|
Proportion of participants preferring the treatment plan.
|
at baseline
|
Change in Cigarette Use
Time Frame: 6 months
|
Cigarette use will be recorded at weeks one, four, eight and at 6 months.
|
6 months
|
Drug Compliance
Time Frame: 6 months
|
Subjects who complete 75% of the planned dosages of therapy will be considered compliant.
|
6 months
|
Counselling Compliance
Time Frame: 6 months
|
Subjects who complete 60% of planned therapy sessions will be considered compliant.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients requiring financial assistance with medication.
Time Frame: 6 months
|
Number of patients requiring financial assistance with medication.
|
6 months
|
Number of patients with alteration in therapy
Time Frame: 6 months
|
Number of patients with alteration in therapy due to ongoing cancer treatment.
|
6 months
|
Insurance coverage
Time Frame: 6 months
|
Proportion of treatments covered by insurance/third party.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph Valentino, MD, University of Kentucky
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms, Second Primary
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Nicotine
- Bupropion
- Varenicline
Other Study ID Numbers
- MCC-20-MULTI-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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