Current SmokerEarly Phase 1NCT02582008
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
A Early Phase 1 study testing Bupropion Hydrochloride, Laboratory Biomarker Analysis and Nicotine Replacement in people with Current Smoker and Head and Neck Squamous Cell Carcinoma, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Current Smoker, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma
- What is being tested?
- Bupropion Hydrochloride, Laboratory Biomarker Analysis and Nicotine Replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to 6 Sep 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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.
- Conditions
- Current Smoker, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma, Oral Cavity Squamous Cell Carcinoma
- Being tested
- Bupropion Hydrochloride, Laboratory Biomarker Analysis, Nicotine Replacement, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion HydrochlorideDrug
Also called Amfebutamone, BW 323U66, Forfivo XL, Wellbutrin
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Given NRT
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
VareniclineDrug
Also called Champix, Chantix, CP-526555
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (bupropion hydrochloride) | Experimental | Patients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT. Receives: 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. Receives: Other: Laboratory Biomarker Analysis; Drug: Nicotine Replacement; Other: Questionnaire Administration; Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months post RT or CRT
Secondary outcomes (5)
Levels of depression and anxiety as measured by Hamilton Rating Scale-Depression questionnaire
Compared using two sample t-tests.
Measured: Up to 12 months
Proportion of patients who are not smoking at 6 months post RT or CRT
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.
Measured: At 6 months
Proportion of patients who develop mucositis and mucositis-related pain evaluated by Common Terminology Criteria for Adverse Events
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.
Measured: Up to 2 weeks post RT or CRT
Proportion of patients who experience smoking relapse among patients who quit smoking
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.
Measured: At 12 months post RT or CRT
QOL as measured by MD Anderson Inventory
Compared using two sample t-tests.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJan 2016
- Primary completion6 Oct 2018
- Study completion6 Sep 2019
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Current SmokerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mercedes Porosnicu, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582008
- Sponsor's protocol ID
- IRB00035113
- Other IDs
- NCI-2015-01714, CCCWFU # 98415, CCCWFU 98415, P30CA012197
- Status last verified
- Jun 2021
- First submitted
- 13 Oct 2015
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 33605440
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation in Patients With Squamous Cell Cancer of the Head and Neck Undergoing Radiation Therapy With or Without Chemotherapy
- ClinicalTrials.gov ID
- NCT02582008
- Acronym / sponsor ID
- IRB00035113
- Conditions
- Current Smoker, Head and Neck Squamous Cell Carcinoma, Hypopharyngeal Squamous Cell Carcinoma, Laryngeal Squamous Cell Carcinoma, Nasopharyngeal Carcinoma, Oral Cavity Squamous Cell Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2016
- Primary completion
- 6 Oct 2018 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (bupropion hydrochloride) | Experimental | Drug: Bupropion Hydrochloride, Other: Laboratory Biomarker Analysis, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive bupropion hydrochloride PO for 3 days and then BID for up to 1 year post RT/CRT. |
| Arm B (varenicline, NRT) | Active comparator | Other: Laboratory Biomarker Analysis, Drug: Nicotine Replacement, Other: Questionnaire Administration, Drug: VareniclinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion HydrochlorideAlso: Amfebutamone, BW 323U66, Forfivo XL, WellbutrinGiven PO | Drug | Arm A (bupropion hydrochloride) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm A (bupropion hydrochloride), Arm B (varenicline, NRT) |
| Nicotine ReplacementAlso: Nicotine Replacement Therapy, NRTGiven NRT | Drug | Arm B (varenicline, NRT) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (bupropion hydrochloride) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (bupropion hydrochloride), Arm B (varenicline, NRT) |
| VareniclineAlso: Champix, Chantix, CP-526555Given PO | Drug | Arm B (varenicline, NRT) |
Primary outcome
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.
5 secondary outcomes
Levels of depression and anxiety as measured by Hamilton Rating Scale-Depression questionnaire
Time frame: Up to 12 months
Proportion of patients who are not smoking at 6 months post RT or CRT
Time frame: 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
Proportion of patients who experience smoking relapse among patients who quit smoking
Time frame: At 12 months post RT or CRT
QOL as measured by MD Anderson Inventory
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 33605440Holliday 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedes Porosnicu principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bupropion Hydrochloride, Laboratory Biomarker Analysis and Nicotine Replacement in people with Current Smoker and Head and Neck Squamous Cell Carcinoma, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who are not smoking (time frame: At 12 months post RT or CRT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02582008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.