Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000165280
Ethics application status
Approved
Date submitted
11/01/2018
Date registered
2/02/2018
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Smoking cessation and effects of cigarette smoking on cure and side effects of treatment in patients with cancer in the head and neck region.
Scientific title
Smoking and its impact on treatment outcome and survival in head and neck cancer patients: a longitudinal observational study
Secondary ID [1] 293762 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Cancer 306153 0
Cigarette smoking 306253 0
Condition category
Condition code
Cancer 305262 305262 0 0
Head and neck
Mental Health 305351 305351 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will evaluate the efficacy of the existing smoking cessation program at Townsville Cancer Centre, its impact on smoking behaviour and the effect of smoking cessation on patient outcomes. The smoking cessation strategy includes assessment of smoking status, carbon monoxide breath testing, advice and counselling, pharmacotherapy with Nicotine patches, and referral to GP and/or Quitline. This strategy occurs at diagnosis and continues with ongoing counselling and pharmacotherapy during follow up visits.
The results of this study will help inform patients and health care providers and facilitate improvement in quality of care and patient compliance leading to improved disease control, survival and quality of life.
Patients will be followed up for 5 years from start of treatment.
Intervention code [1] 300014 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304416 0
Smoking cessation rates at 3 months – defined as the number of current smokers who quit
smoking prior to start of treatment (surgery or radiation therapy) and did not relapse. Measured by study specific questionnaire and carbon monoxide breath testing
Timepoint [1] 304416 0
3 months since start of treatment (radiation therapy) for head and neck cancer.
Primary outcome [2] 304417 0
Loco-regional control rate at 2 years – defined as absence of disease at the primary and regional sites, measured from start of treatment (surgery or
radiation therapy) to date of event (local and/or regional relapse)
Timepoint [2] 304417 0
2 years from start of treatment (surgery or radiation therapy)
Secondary outcome [1] 341885 0
Response rates (for patients undergoing primary radiation therapy) – defined as complete
resolution of disease clinically and radiologically at primary and regional sites at week 20 (from start of treatment)
Timepoint [1] 341885 0
week 20 (from start of treatment) - 3 months from completing of treatment (for those undergoing radiation therapy only)
Secondary outcome [2] 341886 0
Overall survival at 3 and 5 years – measured from start of treatment till death due to any
cause.
Timepoint [2] 341886 0
3 and 5 years since start of treatment
Secondary outcome [3] 341887 0
Cause-specific survival at 3 and 5 years – measured from start of treatment till death due to disease.
Timepoint [3] 341887 0
3 and 5 years since start of treatment
Secondary outcome [4] 341888 0
Acute toxicities assessed by Common Terminology Criteria for Adverse Events (CTCAE)v4.0 and Scored Patient-Generated Subjective Global Assessment - for radiotherapy patients only.
Timepoint [4] 341888 0
Within 3 months of start of treatment
Secondary outcome [5] 341889 0
Swallowing dysfunction using AusTOMS scale and Instrumental Swallow Assessment - Radiotherapy patients only.
Timepoint [5] 341889 0
3 and 12 months from end of treatment
Secondary outcome [6] 341890 0
Health Related Quality of life using FACT-H&N (version 4) Quality of Life questionnaire
Timepoint [6] 341890 0
Baseline, start, mid and end of treatment and at 4weeks, 3 months and 12 month post treatment - for radiotherapy patients only
Secondary outcome [7] 341892 0
Exploratory Objectives
Explore barriers to smoking cessation through structured interviews with a sub-group of patients who continue to smoke through treatment.
Timepoint [7] 341892 0
12 months following study entry
Secondary outcome [8] 342158 0
Enteral tube dependence - for radiotherapy patients only
Timepoint [8] 342158 0
3 and 12 months from end of treatment
Secondary outcome [9] 342164 0
This is a composite secondary outcome. Xerostomia and impaired taste - for radiotherapy patients only (using CTCAEv4.0
Timepoint [9] 342164 0
12 months

Eligibility
Key inclusion criteria
Age 18 years or older
Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx, larynx, nasal cavity or paranasal sinuses.
Stage I – IV disease (Any T, Any N M0).
Any smoking status
No distant metastases.
Deemed suitable for curative treatment by the head and neck multi-disciplinary team.
ECOG Performance Status 0-1.
Patients with prior invasive malignancy and disease free for > 3 years.
Synchronous malignancies are eligible if deemed suitable for curative treatment.
No pregnant women.
Provided written Informed Consent for treatment. (only patients who have consented to curative treatment as part of their standard care are eligible for the study)
Provided written Informed Consent for participation in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Histology other than squamous cell carcinoma.
Recurrent disease
Pregnancy.
Prior (megavoltage) radiation therapy to the head and neck region

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Main study:
Hypothesizing that 70% of the participants will stop smoking, our aim is to collect data from minimum 78 participants (current smokers) to determine the smoking cessation percentage with power of 0.90 and type 1 error of 0.05 (Two-tailed t test). We will also collect data from an equal non-smoking group (78) to achieve other objectives of the study. The sample size was calculated using Open Epi, version 3 factoring a 10% drop out rate.

Based on our experience, we have around 110 diagnosed annually with head and neck cancers of which 35% of them are smokers. To collect data from 78 of smokers over three years will be achievable.

Sub Study:
20 participants i.e. 10 from each group (current smokers and who have quit smoking)

Interim Analyses
The first interim analysis will occur at 15 months. This will contain the patient accrual rate, distribution of important baseline prognostic variables, smoking cessation rates, disease response rates, and frequency of toxicities. Statistical analysis will involve, as appropriate, paired-samples T-Tests, McNemar tests and paired Wilcoxon tests (for two group analysis), and repeated measures ANOVAs and Friedman tests (for analysis involving the 3 curative groups of surgery versus radiotherapy versus radiotherapy & surgery). Survival analysis will also be undertaken in the main 5-year follow-up study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/02/2018
Actual
6/02/2021
Date of last participant enrolment
Anticipated
1/10/2021
Actual
Date of last data collection
Anticipated
1/01/2026
Actual
Sample size
Target
156
Accrual to date
82
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9732 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 18510 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 298377 0
Hospital
Name [1] 298377 0
Study, Education and Research Trust Funding, Townsville Hospital
Country [1] 298377 0
Australia
Primary sponsor type
Individual
Name
MADHAVI CHILKURI
Address
Townsville Hospital and Health Service
P O BOX 670
TOWNSVILLE QLD 4810
Country
Australia
Secondary sponsor category [1] 297503 0
Individual
Name [1] 297503 0
SARAH DEACON
Address [1] 297503 0
Townsville Hospital and Health Service
P O BOX 670
TOWNSVILLE
QLD 4810
Country [1] 297503 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299370 0
HREC Townsville Hospital and Health Service
Ethics committee address [1] 299370 0
Ethics committee country [1] 299370 0
Australia
Date submitted for ethics approval [1] 299370 0
23/10/2017
Approval date [1] 299370 0
08/01/2018
Ethics approval number [1] 299370 0
HREC/17/QTHS/223_4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80206 0
Dr MADHAVI CHILKURI
Address 80206 0
Townsville Hospital and Health Service
P O BOX 670
Townsville
QLD 4814
Country 80206 0
Australia
Phone 80206 0
+61744331801
Fax 80206 0
Email 80206 0
[email protected]
Contact person for public queries
Name 80207 0
MADHAVI CHILKURI
Address 80207 0
Townsville Hospital and Health Service
P O BOX 670
Townsville
QLD 4814
Country 80207 0
Australia
Phone 80207 0
+61744331801
Fax 80207 0
Email 80207 0
[email protected]
Contact person for scientific queries
Name 80208 0
MADHAVI CHILKURI
Address 80208 0
Townsville Hospital and Health Service
P O BOX 670
Townsville
QLD 4814
Country 80208 0
Australia
Phone 80208 0
+61744331801
Fax 80208 0
Email 80208 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual patient data underlying published results only
When will data be available (start and end dates)?
2 years following end of study and publication, starting March 1, 2026 to March 1 2030.
Available to whom?
researchers who provide a methodologically sound proposal.
Available for what types of analyses?
IPD meta-analysis
How or where can data be obtained?
Subject to approval. by PI and requirement to sign data access agreement.
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSmoking cessation in head and neck cancer patients: Factors influencing successes and failures.2021https://dx.doi.org/10.1111/1754-9485.13158
N.B. These documents automatically identified may not have been verified by the study sponsor.