Brief Title
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
Official Title
Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy
Brief Summary
This pilot randomized clinical trial studies how well bupropion hydrochloride works compared
with patient's choice for quitting smoking in patients with squamous cell head and neck
cancer undergoing radiation therapy with or without chemotherapy. Bupropion hydrochloride may
help patients quit smoking by enhancing central nervous system neurotransmitters
noradrenergic and dopaminergic release. It is not yet known whether bupropion hydrochloride
is more effective than patient's choice in helping quit smoking in patients with squamous
cell head and neck cancer undergoing radiation therapy with or without chemotherapy.
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Proportion of patients who are not smoking
Secondary Outcome
Levels of depression and anxiety as measured by Hamilton Rating Scale-Depression questionnaire
Condition
Current Smoker
Intervention
Bupropion Hydrochloride
Study Arms / Comparison Groups
Arm A (bupropion hydrochloride)
Description: Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
January 2016
Completion Date
January 2021
Primary Completion Date
October 6, 2018
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed squamous cell carcinoma
of the nasopharynx, oropharynx, larynx, hypopharynx, oral cavity
- 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 receive RT or CRT with palliative intent and have a prognosis of less
than one year survival
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mercedes Porosnicu, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02582008
Organization ID
IRB00035113
Secondary IDs
NCI-2015-01714
Responsible Party
Sponsor
Study Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Mercedes Porosnicu, Principal Investigator, Wake Forest University Health Sciences
Verification Date
October 2020