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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bupropion; Nicotine; Varenicline

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