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

March 17, 2023 updated by: Wake Forest University Health Sciences

Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Bupropion Hydrochloride
Given PO
Other Names:
  • Wellbutrin
  • Zyban
  • Amfebutamone
  • BW 323U66
  • Forfivo XL
Active Comparator: 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.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Questionnaire Administration
Ancillary studies
Drug: Nicotine Replacement
Given NRT
Other Names:
  • Nicotine Replacement Therapy
  • NRT
Drug: Varenicline
Given PO
Other Names:
  • Champix
  • Chantix
  • CP-526555

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who are not smoking
Time Frame: At 12 months post RT or CRT
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of depression and anxiety as measured by Hamilton Rating Scale-Depression questionnaire
Time Frame: Up to 12 months
Compared using two sample t-tests.
Up to 12 months
Proportion of patients who are not smoking at 6 months post RT or CRT
Time Frame: At 6 months
Study arms will be compared using Fisher's exact tests. Proportions and 95% exact Clopper Pearson confidence intervals will be estimated for each group as well.
At 6 months
Proportion of patients who develop mucositis and mucositis-related pain evaluated by Common Terminology Criteria for Adverse Events
Time Frame: Up to 2 weeks post RT or CRT
This will be examined by treatment group. Within each group will examine the proportion, confidence interval and also the distribution of grade for these measures.
Up to 2 weeks post RT or CRT
Proportion of patients who experience smoking relapse among patients who quit smoking
Time Frame: At 12 months post RT or CRT
This proportion will be calculated for each group and 95% exact Clopper-Pearson confidence intervals will be estimated. The groups will then be compared using a Fisher's exact test.
At 12 months post RT or CRT
QOL as measured by MD Anderson Inventory
Time Frame: Up to 12 months
Compared using two sample t-tests.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Mercedes Porosnicu, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

October 6, 2018

Study Completion (Actual)

September 6, 2019

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 19, 2015

First Posted (Estimate)

October 21, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00035113
  • P30CA012197 (U.S. NIH Grant/Contract)
  • NCI-2015-01714 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CCCWFU # 98415
  • CCCWFU 98415 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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