Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy

Head and Neck Neoplasms Clinical Trial

Official title:

A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251730
• Other study ID #: 201406075RINC
• Status: Completed
• Phase: Phase 2
• First received: September 17, 2014
• Last updated: May 11, 2016
• Start date: August 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Behavioral:
• Smoking cessation
Refer for smoking cessation

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.	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.	10 weeks	No
Secondary	= Grade 3 acute and late adverse event	The secondary outcomes were to test the efficacy of smoking cessation during radiotherapy on acute and late radiation therapy toxicities, tumor response, patterns of relapse, and overall survival.	2 years	No
Secondary	One- and two-year local-regional control rates	All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.	2 years	No
Secondary	One- and two-year distant metastases-free survival rates	All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.	2 years	No
Secondary	One- and two-year progression-free survival rates	All patients will be evaluated by the treating physician once per week during treatment, and acute toxicities will be rated with CTCAE v4.0. All patients will be followed up every 2-3 months for the first 2 years, every 4 months for the third year, and every 6 months until recurrence or death. Late toxicities will be assessed with late morbidity scoring criteria of Radiation Therapy Oncology Group.	2 years	No