Smoking cessation and effects of cigarette smoking on cure and side effects of treatment in patients with cancer in the head and neck region.

Not Applicable

Recruiting

• Conditions: Head and Neck Squamous Cell Cancer; Cigarette smoking; Cancer - Head and neck; Mental Health - Addiction

• Registration Number: ACTRN12618000165280
• Lead Sponsor: MADHAVI CHILKURI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-02
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 156

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.

Exclusion Criteria

Histology other than squamous cell carcinoma.
Recurrent disease
Pregnancy.
Prior (megavoltage) radiation therapy to the head and neck region

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Smoking cessation rates at 3 months – defined as the number of current smokers who quit<br>smoking prior to start of treatment (surgery or radiation therapy) and did not relapse. Measured by study specific questionnaire and carbon monoxide breath testing [3 months since start of treatment (radiation therapy) for head and neck cancer. ];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<br>radiation therapy) to date of event (local and/or regional relapse)[2 years from start of treatment (surgery or radiation therapy)]