Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
Smoking during radiotherapy in head and neck cancers yields not only more radiotherapy acute and late complications but also poor clinical tumor response, poor local control, and poor overall survival. However, smoking cessation has not been included into the standard intervention in treating head and neck cancer patients in Taiwan. We propose a prospective study of introducing a smoking cessation program in head and neck cancer patients receiving radiotherapy. The study will feature the feasibility, safety, and efficacy of a prospective smoking cessation program during head and neck irradiation. The primary outcome is to test the feasibility of the smoking cessation intervention, and the secondary outcome is to test the efficacy of the intervention during radiotherapy on acute and late RT toxicities, tumor response, patterns of relapse, and overall survival.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
64 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal