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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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Wake Forest University Health Sciences
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT02582008
First received: October 13, 2015
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • QOL as measured by MD Anderson Inventory [ Time Frame: Up to 12 months ]
    Compared using two sample t-tests.


Estimated Enrollment: 60
Study Start Date: January 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT.
Drug: Bupropion Hydrochloride
Given PO
Other Names:
  • Amfebutamone
  • BW 323U66
  • Forfivo XL
  • Wellbutrin
  • Zyban
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
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
Drug: Nicotine Replacement
Given NRT
Other Names:
  • Nicotine Replacement Therapy
  • NRT
Other: Questionnaire Administration
Ancillary studies
Drug: Varenicline
Given PO
Other Names:
  • Champix
  • Chantix
  • CP-526555

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02582008

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mercedes Porosnicu    336-716-8664    mporosni@wakehealth.edu   
Principal Investigator: Mercedes Porosnicu         
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: Graham Warren    843-876-2295    warrengw@musc.edu   
Principal Investigator: Graham Warren         
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mercedes Porosnicu Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02582008     History of Changes
Other Study ID Numbers: CCCWFU 98415
NCI-2015-01714 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU # 98415
CCCWFU 98415 ( Other Identifier: Wake Forest University Health Sciences )
P30CA012197 ( U.S. NIH Grant/Contract )
Study First Received: October 13, 2015
Last Updated: May 30, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nicotine
Varenicline
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 25, 2017