Head and Neck Squamous Cell CarcinomaNCT05412875
Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
A study testing Best Practice, Nicotine Replacement and Quality-of-Life Assessment in people with Head and Neck Squamous Cell Carcinoma and Lung Non-Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Lung Non-Small Cell Carcinoma, Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
- What is being tested?
- Best Practice, Nicotine Replacement and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed lung cancer subjects will be stages I-III non-small cell lung cancer (NSCLC) and head and neck cancer subjects will be stages I-IV squamous cell carcinoma (SCC).
- Current smokers of combustible cigarettes who smoke >= 4 days/week.
- Lung cancer patients planning to undergo wedge resection surgery for their index cancer.
- Head and neck cancer patients planning to undergo surgical resection of their index cancer or exploratory biopsies (tonsil cancer).
- Patients must intend to receive ongoing oncology care at Ohio State University [OSU] (i.e., their clinic visit is not a consultation/second opinion).
- Patients that are over the age of 21 years.
Who cannot join
- Patients who are cognitively unable to understand the consent form or participate in interviews.
- Patients with hearing impairments.
- Patients who are planning to use or are currently using cessation medication to help quit or reduce smoking.
- Patients who are currently using e-cigarettes.
- Patients undergoing surgery including lobectomy, pneumonectomy, tracheotomy, laryngectomy, or free flap surgery.
- Patients with contraindications to per oral intake.
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- Lung cancer patients who are on home supplemental oxygen at baseline.
- Patients that have problems with dexterity that would impact electronic cigarette use.
- Patients under 21 years of age.
- Patients who don't speak and read English.
- Patients with histologies other than NSCLC, or squamous cell carcinoma of the head and neck.
- Patients with nasopharyngeal, thyroid, or gland cancers.
- Patients with inoperable tumors.
- Pregnant women.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Being tested
- Best Practice, Nicotine Replacement, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Given usual care
Nicotine ReplacementDrug
Also called Nicotine Replacement Therapy, NRT
Given JUUL
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (JUUL) | Experimental | 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. Receives: Drug: Nicotine Replacement; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients receive usual care. Receives: Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of patients measured by number of screened per month
Will be measured by the number of screened patients per month.
Measured: Up to 6 months
Feasibility of patients measured by number of screened per month by eligibility status
Will be measured by the number of screened patients per month by eligibility status.
Measured: Up to 6 months
Feasibility of patients measured by number of screened per month by refusal status
Will be measured by the number of screened patients per month by refusal status.
Measured: Up to 6 months
Reasons for participant ineligibility
We will record reasons for patient ineligibility
Measured: Baseline
Reasons for participant refusal
We will record reasons for patient refusal to participate
Measured: Baseline
Acceptance measured by participation rate
Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.
Measured: Up to 6 months
Compliance
Will be self-reported and include counting of used JUUL pods on follow-ups interviews.
Measured: Up to 6 months
Adherence
Further, exhaled carbon monoxide (a marker of short-term smoking status) will be assessed at baseline and upon hospital admission for surgery.
Measured: Baseline and hospital admission for surgery
Incidence of adverse events (AEs)
Will be assessed at days 2 and 14 following the delivery of the intervention and reported by participants. Further, participants will be invited to contact the research team to report any adverse events related to the use of the intervention at any time point.
Measured: Up to 14 days after delivery of intervention
Complication rate (primary preliminary efficacy)
Will be measured as the number of complications reported, per person month of follow up.
Measured: Up to 6 months
Quality of life (QOL) - anxiety & depression
Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)
Measured: Up to 6 months
Quality of life (QOL) - anxiety & depression 2
Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)
Measured: Up to 6 months
Quality of life (QOL) - Perceptions of cancer
Self-reported QOL measures will include the Perceptions of Lung Cancer to assess views on their disease (modified slightly for head and neck cancer patients)
Measured: Up to 6 months
Quality of life (QOL) - Health outcomes
Self-reported QOL measures will include the EQ-5D-5L to assess overall and cancer-specific health outcomes (including cough, dyspnea, dysphagia, and pain).
Measured: Up to 6 months
Quality of life (QOL) - Health outcomes 2
Self-reported QOL measures will include the and EORTC-QLQ-LC13 to assess overall and cancer-specific health outcomes (including cough, dyspnes, dysphagia, and pain).
Measured: Up to 6 months
7 day point prevalence of tobacco use
7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Jan 2024
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Funding lapse
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Theodore Brasky PhD, Ohio State University Comprehensive Cancer Center
- Investigators
- Theodore Brasky, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412875
- Sponsor's protocol ID
- OSU-21255
- Other IDs
- NCI-2022-00864, K07CA215546
- Status last verified
- Apr 2024
- First submitted
- 17 May 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
- ClinicalTrials.gov ID
- NCT05412875
- Acronym / sponsor ID
- OSU-21255
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding lapse
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (JUUL) | Experimental | Drug: Nicotine Replacement, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationBeginning 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 (usual care) | Active comparator | Other: Best Practice, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive usual care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Newly diagnosed lung cancer subjects will be stages I-III non-small cell lung cancer (NSCLC) and head and neck cancer subjects will be stages I-IV squamous cell carcinoma (SCC).
- Current smokers of combustible cigarettes who smoke >= 4 days/week.
- Lung cancer patients planning to undergo wedge resection surgery for their index cancer.
- Head and neck cancer patients planning to undergo surgical resection of their index cancer or exploratory biopsies (tonsil cancer).
- Patients must intend to receive ongoing oncology care at Ohio State University [OSU] (i.e., their clinic visit is not a consultation/second opinion).
Key exclusion criteria (15 listed)
- Patients who are cognitively unable to understand the consent form or participate in interviews.
- Patients with hearing impairments.
- Patients who are planning to use or are currently using cessation medication to help quit or reduce smoking.
- Patients who are currently using e-cigarettes.
- Patients undergoing surgery including lobectomy, pneumonectomy, tracheotomy, laryngectomy, or free flap surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyGiven usual care | Other | Arm II (usual care) |
| Nicotine ReplacementAlso: Nicotine Replacement Therapy, NRTGiven JUUL | Drug | Arm I (JUUL) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (JUUL), Arm II (usual care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (JUUL), Arm II (usual care) |
Primary outcome
Feasibility of patients measured by number of screened per month
Time frame: Up to 6 months
Will be measured by the number of screened patients per month.
Feasibility of patients measured by number of screened per month by eligibility status
Time frame: Up to 6 months
Will be measured by the number of screened patients per month by eligibility status.
Feasibility of patients measured by number of screened per month by refusal status
Time frame: Up to 6 months
Will be measured by the number of screened patients per month by refusal status.
Reasons for participant ineligibility
Time frame: Baseline
We will record reasons for patient ineligibility
Reasons for participant refusal
Time frame: Baseline
We will record reasons for patient refusal to participate
Acceptance measured by participation rate
Time frame: Up to 6 months
Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.
Compliance
Time frame: Up to 6 months
Will be self-reported and include counting of used JUUL pods on follow-ups interviews.
Adherence
Time frame: Baseline and hospital admission for surgery
Further, exhaled carbon monoxide (a marker of short-term smoking status) will be assessed at baseline and upon hospital admission for surgery.
Incidence of adverse events (AEs)
Time frame: Up to 14 days after delivery of intervention
Will be assessed at days 2 and 14 following the delivery of the intervention and reported by participants. Further, participants will be invited to contact the research team to report any adverse events related to the use of the intervention at any time point.
Complication rate (primary preliminary efficacy)
Time frame: Up to 6 months
Will be measured as the number of complications reported, per person month of follow up.
Quality of life (QOL) - anxiety & depression
Time frame: Up to 6 months
Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)
Quality of life (QOL) - anxiety & depression 2
Time frame: Up to 6 months
Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)
Quality of life (QOL) - Perceptions of cancer
Time frame: Up to 6 months
Self-reported QOL measures will include the Perceptions of Lung Cancer to assess views on their disease (modified slightly for head and neck cancer patients)
Quality of life (QOL) - Health outcomes
Time frame: Up to 6 months
Self-reported QOL measures will include the EQ-5D-5L to assess overall and cancer-specific health outcomes (including cough, dyspnea, dysphagia, and pain).
Quality of life (QOL) - Health outcomes 2
Time frame: Up to 6 months
Self-reported QOL measures will include the and EORTC-QLQ-LC13 to assess overall and cancer-specific health outcomes (including cough, dyspnes, dysphagia, and pain).
7 day point prevalence of tobacco use
Time frame: Up to 6 months
7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore Brasky, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Nicotine Replacement and Quality-of-Life Assessment in people with Head and Neck Squamous Cell Carcinoma and Lung Non-Small Cell Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of patients measured by number of screened per month (time frame: Up to 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.