Bupropion Hydrochloride or Patient's Choice for Smoking Cessation in Patients With Squamous Cell Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
NCT ID: NCT02582008
Last Updated: 2023-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
9 participants
INTERVENTIONAL
2016-01-31
2019-09-06
Brief Summary
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Detailed Description
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I. To estimate the proportion of patients who are not smoking (successful quitters) at 12 months post-radiation therapy (RT)/chemotherapy and radiation therapy (CRT) and compare proportions between the two study arms.
SECONDARY OBJECTIVES:
I. To compare the proportion of patients who are not smoking at 6 months post-RT/CRT between the two study arms.
II. Among patients who quit smoking, determine the proportion of patients who experience smoking relapse at 12 months post-RT/CRT and compare between the two study arms.
III. To compare the maximum degree of mucositis and mucositis-related pain during radiation treatment and the following week post-treatment between the two study arms.
IV. Determine the impact of study treatment on anxiety, depression and quality of life (QOL) and compare between two study arms.
V. Collect descriptive data assessing smoking status among caregivers and corresponding data concerning whether smoking relapse occurs in our patient population.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive bupropion hydrochloride orally (PO) for 3 days and then twice daily (BID) for up to 1 year post RT/CRT.
ARM B: Patients receive smoking cessation treatment tailored to individual smokers based on preference, smoking history and contra-indications. Patients are given the choice of one of the National Comprehensive Cancer Network (NCCN)-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily for 1 week and then BID for 12 weeks or combination of nicotine patch and acute nicotine replacement therapy (NRT) for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Treatment with varenicline or NRT can be extended up to 6 months to 1 year as needed.
After completion of study, patients are followed up for 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
Bupropion Hydrochloride
Given PO
Laboratory Biomarker Analysis
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm B (varenicline, NRT)
Patients receive smoking cessation treatment tailored to individual smokers based on preference, smoking history and contra-indications. Patients are given the choice of one of the NCCN-recommended first-line pharmacotherapy options for smoking cessation comprised of varenicline PO daily for 1 week and then BID for 12 weeks or combination of nicotine patch and acute NRT for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Treatment with varenicline or NRT can be extended up to 6 months to 1 year as needed.
Laboratory Biomarker Analysis
Correlative studies
Nicotine Replacement
Given NRT
Questionnaire Administration
Ancillary studies
Varenicline
Given PO
Interventions
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Bupropion Hydrochloride
Given PO
Laboratory Biomarker Analysis
Correlative studies
Nicotine Replacement
Given NRT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Varenicline
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be scheduled to receive RT or CRT as definitive treatment or surgery with planned adjuvant RT or CRT treatment post-surgery per surgeon or Head and Neck Cancer (HNC) Tumor Board decision
* Patients should receive their definitive treatment at Wake Forest University (WFU) Cancer Center or at Medical University of South Carolina (MUSC) Cancer Center
* Patients must be active smokers (defined as smoking any cigarette, cigar or pipe in the last 30 days)
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria
* Patients who chew tobacco and patients who are not smoking but are exposed to second hand smoking are excluded from this study
* Patients currently using a smoking cessation treatment
* Other known drug use/abuse
* Patients with documented contraindications for bupropion (bupropion hydrochloride), including: bulimia nervosa, anorexia nervosa; use of monoamine oxidase inhibitors in the past two weeks; documented seizure disorders or predisposition to seizure (ie stroke, brain metastases); abrupt withdrawal from alcohol, benzodiazepines, or other sedatives; closed-angle glaucoma
* Patients with diagnosis of major depression or any other psychiatric disorders
* Documented history of allergic reactions attributed to compounds of similar chemical or biologic composition to buproprion
* Any other significant acute or chronic diseases that in the investigator's opinion would exclude the subject from the trial
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Mercedes Porosnicu
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2015-01714
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU # 98415
Identifier Type: -
Identifier Source: secondary_id
CCCWFU 98415
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00035113
Identifier Type: -
Identifier Source: org_study_id
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