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

NCT02582008 | Terminated Early Phase 1 FDA Drug

• 5 other identifiers: IRB00035113NCI-2015-01714CCCWFU # 98415CCCWFU 98415P30CA012197
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who are not smoking

  Observed rates of patients who are not smoking at 12 months and corresponding 95% exact Clopper-Pearson confidence intervals will be estimated. Next, will perform a Fisher's exact test to determine whether the proportion of patients who are not smoking at 12 months post-RT/CRT in the bupropion hydrochloride group and the patient's choice group are different.

  At 12 months post RT or CRT

Secondary Outcomes (5)

• Levels of depression and anxiety as measured by Hamilton Rating Scale-Depression questionnaire

  Up to 12 months

• Proportion of patients who are not smoking at 6 months post RT or CRT

  At 6 months

• Proportion of patients who develop mucositis and mucositis-related pain evaluated by Common Terminology Criteria for Adverse Events

  Up to 2 weeks post RT or CRT

• Proportion of patients who experience smoking relapse among patients who quit smoking

  At 12 months post RT or CRT

• QOL as measured by MD Anderson Inventory

  Up to 12 months

Study Arms (2)

Arm A (bupropion hydrochloride)

EXPERIMENTAL

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

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

Arm B (varenicline, NRT)

ACTIVE COMPARATOR

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.

Other: Laboratory Biomarker Analysis; Drug: Nicotine Replacement; Other: Questionnaire Administration; Drug: Varenicline

Interventions

Bupropion Hydrochloride DRUG

Given PO

Also known as: Amfebutamone, BW 323U66, Forfivo XL, Wellbutrin, Zyban

Arm A (bupropion hydrochloride)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm A (bupropion hydrochloride); Arm B (varenicline, NRT)

Nicotine Replacement DRUG

Given NRT

Also known as: Nicotine Replacement Therapy, NRT

Arm B (varenicline, NRT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (bupropion hydrochloride)

Questionnaire Administration OTHER

Ancillary studies

Arm A (bupropion hydrochloride); Arm B (varenicline, NRT)

Varenicline DRUG

Given PO

Also known as: Champix, Chantix, CP-526555

Arm B (varenicline, NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 33605440 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Nasopharyngeal Carcinoma

Interventions

Bupropion; Nicotine Replacement Therapy; Varenicline

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Drug Therapy; Therapeutics; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Mercedes Porosnicu

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 21, 2015
• Study Start: January 1, 2016
• Primary Completion: October 6, 2018
• Study Completion: September 6, 2019
• Last Updated: March 22, 2023

Record last verified: 2021-06

Locations

US (2)