Head and Neck NeoplasmsPhase 2NCT02251730
Smoking Cessation in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
A Phase 2 study testing Smoking cessation in people with Head and Neck Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Smoking cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Smoking cessation
- Keywords
- radiation therapy,Smoking pattern,head and neck cancer
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessationBehavioural
Refer for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Refer for smoking cessation | Experimental | Refer for smoking cessation Receives: Behavioral: Smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (4)
≥ 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Ling-Yu Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251730
- Sponsor's protocol ID
- 201406075RINC
- Status last verified
- May 2016
- First submitted
- 17 Sep 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility and Efficacy Study of Smoking Cessation Program in Head and Neck Cancer Patients Receiving Curative Radiation Therapy
- ClinicalTrials.gov ID
- NCT02251730
- Acronym / sponsor ID
- 201406075RINC
- Conditions
- Head and Neck Neoplasms
- Keywords
- radiation therapy,Smoking pattern,head and neck cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refer for smoking cessation | Experimental | Behavioral: Smoking cessationRefer for smoking cessation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessationRefer for smoking cessation | Behavioural | Refer for smoking cessation |
Primary outcome
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.
4 secondary outcomes
≥ Grade 3 acute and late adverse event
Time frame: 2 years
One- and two-year local-regional control rates
Time frame: 2 years
One- and two-year distant metastases-free survival rates
Time frame: 2 years
One- and two-year progression-free survival rates
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Ling-Yu Chen principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Smoking cessation in people with Head and Neck Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful smoking cessation at the end of radiotherapy, confirmed by CO breath test concentrations of 3 ppm or less. (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.