Clinical trial NCT02251730: Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
Official title: A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Keywords: radiation therapy,Smoking pattern,head and neck cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-09-29
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.
timeFrame: 10 weeks
Secondary outcomes:
measure: ≥ Grade 3 acute and late adverse event
timeFrame: 2 years
measure: One- and two-year local-regional control rates
timeFrame: 2 years
measure: One- and two-year distant metastases-free survival rates
timeFrame: 2 years
measure: One- and two-year progression-free survival rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jenny Ling-Yu Chen
role: PRINCIPAL_INVESTIGATOR
References: