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

Wake Forest University (WFU)

Status and phase: Terminated; Early Phase 1

Conditions: Hypopharyngeal Squamous Cell Carcinoma; Nasopharyngeal Carcinoma; Oral Cavity Squamous Cell Carcinoma; Laryngeal Squamous Cell Carcinoma; Current Smoker; Oropharyngeal Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma

Treatments: Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Drug: Varenicline; Other: Questionnaire Administration; Drug: Bupropion Hydrochloride; Drug: Nicotine Replacement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02582008

P30CA012197 (U.S. NIH Grant/Contract)

CCCWFU # 98415

NCI-2015-01714 (Registry Identifier)

IRB00035113

CCCWFU 98415 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Arm A (bupropion hydrochloride)

Experimental group

Description:

Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.

Treatment:

Drug: Bupropion Hydrochloride

Other: Laboratory Biomarker Analysis

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Arm B (varenicline, NRT)

Active Comparator group

Description:

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.

Treatment:

Drug: Nicotine Replacement

Other: Laboratory Biomarker Analysis

Drug: Varenicline

Other: Questionnaire Administration