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

NCT02251730 | Completed Phase 2

• 1 other identifier: 201406075RINC
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Neoplasms

Keywords

radiation therapy,Smoking pattern,head and neck cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ≥ Grade 3 acute and late adverse event

  2 years

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

  2 years

• One- and two-year distant metastases-free survival rates

  2 years

• One- and two-year progression-free survival rates

  2 years

Study Arms (1)

Refer for smoking cessation

EXPERIMENTAL

Refer for smoking cessation

Behavioral: Smoking cessation

Interventions

Smoking cessation BEHAVIORAL

Refer for smoking cessation

Refer for smoking cessation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Jenny Ling-Yu Chen

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 29, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

TW (1)