Can a tailored Stop-Smoking program help cancer patients quit?
NCT ID NCT04694846
First seen Jun 26, 2026 ยท Last updated Jun 26, 2026
Summary
This study tested an enhanced tobacco intervention program (ETIP) for people with head and neck or lung cancer who smoke. The program combined counseling, nicotine replacement, and medications like bupropion or varenicline. Nineteen participants were enrolled to see if the program could reduce smoking by at least half. The goal was to help patients quit smoking to potentially improve their cancer treatment outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nicotine replacement therapy, bupropion, and varenicline
- What this could lead to
- If successful, this approach could help cancer patients quit smoking, potentially improving treatment outcomes and reducing cancer progression.
- What could go wrong
- This was a small feasibility study with only 19 participants, so results may not apply broadly. The intervention may not lead to long-term abstinence or affect tumor biology.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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19 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Provide signed written informed consent document * New patients opting to receive cancer care at Thomas Jefferson University Hospital (TJUH) or Methodist with suspected or newly diagnosed head and neck squamous cell carcinoma (HNSCC) or non-small cell carcinoma of the lung * Must have a life expectancy of at least 6 months as judged by the treating physician * Willing to discuss changing their smoking behavior * Patients have smoked \> 100 cigarettes in their lifetime and have smoked within the last 30 days * Subjects must read and speak fluent English Exclusion Criteria: * Patients with psychiatric disorders with indications of current uncontrolled illness, or patients currently being treated on psychiatric medications * Patients with expected survival of less than 6 months or other medical illness that would prevent participation as determined by the treating clinician * Patients not fluent in English will be excluded, as the counselling component of the intervention is only available in English * Pregnant or breastfeeding women * Severe swallowing disorders or other illness that would impede a patient's ability to swallow medications in pill form * Patients with impaired judgement or those unable to provide informed consent * Contraindications to nicotine replacement therapy: * All free flap patients: Nicotine replacement therapy (NRT) and tobacco products must not be used by these patients for at least 2 weeks before and 2 weeks after free flap surgery. For planned procedures involving face and breast, tobacco and NRT use should be avoided 4 weeks before and 4 weeks after surgery * Patients in the immediate (within 2 weeks) post myocardial infarction period or who have serious arrhythmias or unstable angina pectoris * Patient who are hemodynamically or electrically unstable or have had orthopedic surgery or a serious fracture(s) within the past 6 weeks * Patients with known allergy or hypersensitivity to NRT, or severe skin reactions like Steven's Johnson syndrome * Contraindications to bupropion or varenicline: * Pre-existing seizure disorder or conditions that increase the risk of seizures (e.g., severe head trauma, arteriovenous malformation, central nervous system (CNS) tumor (e.g., brain tumor or intracranial mass), CNS infection, severe stroke, anorexia nervosa, bulimia nervosa * Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs * Concomitant use of anti-depressants * Patients with known allergy or hypersensitivity to bupropion or varenicline, or severe skin reactions like Steven's Johnson syndrome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Jefferson Health, Methodist Hospital
Philadelphia, Pennsylvania, 19148, United States
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Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, 19107, United States
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