ANZCTR - Registration

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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]

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

Cigarette smoking

Condition category

Condition code

Cancer

Head and neck

Mental Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

3 months since start of treatment (radiation therapy) for head and neck cancer.

Primary outcome [2]

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]

2 years from start of treatment (surgery or radiation therapy)

Secondary outcome [1]

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]

week 20 (from start of treatment) - 3 months from completing of treatment (for those undergoing radiation therapy only)

Secondary outcome [2]

Overall survival at 3 and 5 years – measured from start of treatment till death due to any
cause.

Timepoint [2]

3 and 5 years since start of treatment

Secondary outcome [3]

Cause-specific survival at 3 and 5 years – measured from start of treatment till death due to disease.

Timepoint [3]

3 and 5 years since start of treatment

Secondary outcome [4]

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]

Within 3 months of start of treatment

Secondary outcome [5]

Swallowing dysfunction using AusTOMS scale and Instrumental Swallow Assessment - Radiotherapy patients only.

Timepoint [5]

3 and 12 months from end of treatment

Secondary outcome [6]

Health Related Quality of life using FACT-H&N (version 4) Quality of Life questionnaire

Timepoint [6]

Baseline, start, mid and end of treatment and at 4weeks, 3 months and 12 month post treatment - for radiotherapy patients only

Secondary outcome [7]

Exploratory Objectives
Explore barriers to smoking cessation through structured interviews with a sub-group of patients who continue to smoke through treatment.

Timepoint [7]

12 months following study entry

Secondary outcome [8]

Enteral tube dependence - for radiotherapy patients only

Timepoint [8]

3 and 12 months from end of treatment

Secondary outcome [9]

This is a composite secondary outcome. Xerostomia and impaired taste - for radiotherapy patients only (using CTCAEv4.0

Timepoint [9]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Recruitment postcode(s) [1]

4814 - Douglas

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Study, Education and Research Trust Funding, Townsville Hospital

Address [1]

Townsville Hospital and Health Service
P O BOX 670
TOWNSVILLE, QLD 4810

Country [1]

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]

Individual

Name [1]

SARAH DEACON

Address [1]

Townsville Hospital and Health Service
P O BOX 670
TOWNSVILLE
QLD 4810

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREC Townsville Hospital and Health Service

Ethics committee address [1]

100 Angus Smoth Drive
Douglas 
QLD 4814

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/10/2017

Approval date [1]

08/01/2018

Ethics approval number [1]

HREC/17/QTHS/223_4

Summary

Brief summary

This observational study will evaluate smoking cessation and its impact on treatment outcome and survival in patients with head and neck cancer. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or older and have a confirmed diagnosis of Stage I-IV squamous cell carcinoma of the oral cavity, pharynx, larynx, nasal cavity or paranasal sinuses, for which you are deemed suitable for curative treatment at Townsville Cancer Centre. 

Study details
Participants will undergo cancer treatment and may participate in the existing smoking cessation program as per standard of care at Townsville Cancer Centre. They will then be followed up at 3 months, 6 months, 9 months, 1 year, 2 years, 3 years and 5 years post treatment to evaluate a number of outcomes, including smoking cessation rate among smokers, treatment toxicities, and clinical response to treatment. 

It is hoped that 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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr MADHAVI CHILKURI

Address

Townsville Hospital and Health Service
P O BOX 670
Townsville
QLD 4814

Country

Australia

Phone

+61744331801

Fax

Madhavi.Chilkuri@health.qld.gov.au

Contact person for public queries

Name

MADHAVI CHILKURI

Address

Townsville Hospital and Health Service
P O BOX 670
Townsville
QLD 4814

Country

Australia

Phone

+61744331801

Fax

Madhavi.Chilkuri@health.qld.gov.au

Contact person for scientific queries

Name

MADHAVI CHILKURI

Address

Townsville Hospital and Health Service
P O BOX 670
Townsville
QLD 4814

Country

Australia

Phone

+61744331801

Fax

Madhavi.Chilkuri@health.qld.gov.au

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.
Madhavi.Chilkuri@health.qld.gov.au

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

Source	Title	Year of Publication	DOI
Embase	Smoking cessation in head and neck cancer patients: Factors influencing successes and failures.	2021	https://dx.doi.org/10.1111/1754-9485.13158

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically