Clinical trial · Interventional
Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
NCT02251730CI-TRIAL-00022163completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To propose a feasibility study of introducing a smoking cessation program in head and neck cancer patients with planned radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Smoking cessation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Refer for smoking cessation
- description
- Refer for smoking cessation
- interventionNames
- Behavioral: Smoking cessation
Primary outcomes (1)
- measure
- Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.
- timeFrame
- 10 weeks
- description
- The primary outcome was to test the feasibility of introducing a smoking cessation program in head and neck cancer patients undergoing radiotherapy. Smoking cessation status will be formally assessed by patient report and by carbon monoxide (CO) breath test. The status of tobacco abstinence will be confirmed by carbon monoxide breath test concentrations of 3 ppm or less.
Secondary outcomes (4)
- measure
- ≥ Grade 3 acute and late adverse event
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 to 70 years * Head and Neck Malignancy Stage I-IVB without distant metastasis * Receiving five weeks or more of external beam radiotherapy * Report smoking one or more cigarettes in the past 30 days or self-identify as a smoker * KPS 70-100 Exclusion Criteria: * Serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorders, as assessed by the study-site physician * A current diagnosis of major depressive episode or a history of psychosis, bipolar disorder, or seizure disorder * Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.