Skip to main content
OpenTrials
Completed

NCT Number: NCT02251730

Smoking Cessation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

smoking cessation

Behavioral

Refer for smoking cessation

Primary outcomes

  1. Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. ≥ Grade 3 acute and late adverse event

    Time frame: 2 years

    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. One- and two-year local-regional control rates

    Time frame: 2 years

    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.

  3. One- and two-year distant metastases-free survival rates

    Time frame: 2 years

    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.

  4. One- and two-year progression-free survival rates

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2014
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.