Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
Conditions
Head and Neck Neoplasms
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
radiation therapy,Smoking pattern,head and neck cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Smoking cessation
Type: Behavioral
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 20 Years
Gender: Both
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
Location
National Taiwan University Hospital
Taipei, Taiwan
Status: Recruiting
Contact: Chen Jenny Ling-Yu
Start Date
August 2014
Completion Date
July 2020
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page