Trials / Withdrawn
WithdrawnNCT05412875
Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
This clinical trial investigates the acceptability of electronic cigarettes (JUUL) for smoking cessation (quitting smoking) and the reduction of surgery-related complications in patients with newly diagnosed head, neck, or lung cancer. Smoking before surgery is associated with increased risk of complications during and after surgery. Electronic cigarettes are a type of special product that gives small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking. Stopping cigarette smoking before surgery may reduce the risk of complications during and after surgery in patients with head, neck, or lung cancer.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate feasibility, acceptability, compliance, and safety of a non-randomized 2-month trial of a pod based electronic cigarette (intervention) versus usual care for stage I-III lung cancer patients and stage I-IV head and neck cancer patients undergoing surgical resection. II. Examine the effect of the pod based electronic cigarette (intervention) on surgical complications, quality of life, and whether it promotes complete or incomplete switching to the non-combustible product. OUTLINE: Patients choose to participate in 1 of 2 arms. ARM I: Beginning 1 month before surgery, patients receive a JUUL e-cigarette and a 1 month supply e-liquid pods. After completion of surgery, patients receive another 1 month supply of e-liquid pods. ARM II: Patients receive usual care. After completion of study intervention, patients are followed up at 2 and 6 months.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Lung Non-Small Cell Carcinoma
- Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage I Lung Cancer AJCC v8
- Stage IA1 Lung Cancer AJCC v8
- Stage IA2 Lung Cancer AJCC v8
- Stage IA3 Lung Cancer AJCC v8
- Stage IB Lung Cancer AJCC v8
- Stage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage II Lung Cancer AJCC v8
- Stage IIA Lung Cancer AJCC v8
- Stage IIB Lung Cancer AJCC v8
- Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- Stage III Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Stage IIIB Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Best Practice | Given usual care |
| DRUG | Nicotine Replacement | Given JUUL |
| OTHER | Quality-of-Life Assessment | Ancillary studies |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2024-01-31
- Completion
- 2024-01-31
- First posted
- 2022-06-09
- Last updated
- 2024-04-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05412875. Inclusion in this directory is not an endorsement.