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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Behavioral: Smoking cessation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Refer for smoking cessation	Behavioral: Smoking cessation; Refer for smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
≥ 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
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
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
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Jenny Ling-Yu Chen, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 13, 2016
• Last Update Submitted That Met QC Criteria: May 11, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: radiation therapy,Smoking pattern,head and neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 201406075RINC