Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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23 May 2016 |
Main ID: |
NCT02251730 |
Date of registration:
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17/09/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
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Scientific title:
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A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy |
Date of first enrolment:
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August 2014 |
Target sample size:
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64 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02251730 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Jenny Ling-Yu Chen |
Address:
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Telephone:
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Email:
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Affiliation:
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National Taiwan University Hospital |
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Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Head and Neck Neoplasms
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Intervention(s)
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Behavioral: Smoking cessation
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Primary Outcome(s)
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Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less.
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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One- and two-year local-regional control rates
[Time Frame: 2 years]
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= Grade 3 acute and late adverse event
[Time Frame: 2 years]
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One- and two-year progression-free survival rates
[Time Frame: 2 years]
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One- and two-year distant metastases-free survival rates
[Time Frame: 2 years]
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Secondary ID(s)
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201406075RINC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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