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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Refer for smoking cessation

Group Type EXPERIMENTAL

Smoking cessation

Intervention Type BEHAVIORAL

Refer for smoking cessation

Interventions

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Smoking cessation

Refer for smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No