RecruitingACTRN12618000165280

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

Smoking and its impact on treatment outcome and survival in head and neck cancer patients: a longitudinal observational study

Sponsor

MADHAVI CHILKURI

Enrollment

156 participants

Start Date

Feb 6, 2021

Study Type

Observational

Conditions

Head and Neck Squamous Cell Cancer

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria12

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 Criteria4

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

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Interventions

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.