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Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Lung Non-Small Cell Carcinoma, Stage I Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Nicotine Replacement
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (JUUL)

Arm II (usual care)

Arm Description

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.

Patients receive usual care.

Outcomes

Primary Outcome Measures

Feasibility of patients measured by number of screened per month
Will be measured by the number of screened patients per month.
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.
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.
Reasons for participant ineligibility
We will record reasons for patient ineligibility
Reasons for participant refusal
We will record reasons for patient refusal to participate
Acceptance measured by participation rate
Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.
Compliance
Will be self-reported and include counting of used JUUL pods on follow-ups interviews.
Adherence
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)
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)
Will be measured as the number of complications reported, per person month of follow up.
Quality of life (QOL) - anxiety & depression
Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)
Quality of life (QOL) - anxiety & depression 2
Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)
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)
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).
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).
7 day point prevalence of tobacco use
7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups

Secondary Outcome Measures

Full Information

First Posted
May 17, 2022
Last Updated
August 19, 2022
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05412875
Brief Title
Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung
Official Title
A Pilot Trial of Electronic Cigarettes in Patients Diagnosed With Cancers of the Head, Neck, and Lung
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (JUUL)
Arm Type
Experimental
Arm Description
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 Title
Arm II (usual care)
Arm Type
Active Comparator
Arm Description
Patients receive usual care.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Given usual care
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement
Other Intervention Name(s)
Nicotine Replacement Therapy, NRT
Intervention Description
Given JUUL
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of patients measured by number of screened per month
Description
Will be measured by the number of screened patients per month.
Time Frame
Up to 6 months
Title
Feasibility of patients measured by number of screened per month by eligibility status
Description
Will be measured by the number of screened patients per month by eligibility status.
Time Frame
Up to 6 months
Title
Feasibility of patients measured by number of screened per month by refusal status
Description
Will be measured by the number of screened patients per month by refusal status.
Time Frame
Up to 6 months
Title
Reasons for participant ineligibility
Description
We will record reasons for patient ineligibility
Time Frame
Baseline
Title
Reasons for participant refusal
Description
We will record reasons for patient refusal to participate
Time Frame
Baseline
Title
Acceptance measured by participation rate
Description
Will be measured by the participation rate, the number of eligible participants who consent and agree to study participation.
Time Frame
Up to 6 months
Title
Compliance
Description
Will be self-reported and include counting of used JUUL pods on follow-ups interviews.
Time Frame
Up to 6 months
Title
Adherence
Description
Further, exhaled carbon monoxide (a marker of short-term smoking status) will be assessed at baseline and upon hospital admission for surgery.
Time Frame
Baseline and hospital admission for surgery
Title
Incidence of adverse events (AEs)
Description
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.
Time Frame
Up to 14 days after delivery of intervention
Title
Complication rate (primary preliminary efficacy)
Description
Will be measured as the number of complications reported, per person month of follow up.
Time Frame
Up to 6 months
Title
Quality of life (QOL) - anxiety & depression
Description
Self-reported QOL measures will include the GAD-7 (anxiety and depressive symptoms)
Time Frame
Up to 6 months
Title
Quality of life (QOL) - anxiety & depression 2
Description
Self-reported QOL measures will include the PHQ-9 (anxiety and depressive symptoms)
Time Frame
Up to 6 months
Title
Quality of life (QOL) - Perceptions of cancer
Description
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)
Time Frame
Up to 6 months
Title
Quality of life (QOL) - Health outcomes
Description
Self-reported QOL measures will include the EQ-5D-5L to assess overall and cancer-specific health outcomes (including cough, dyspnea, dysphagia, and pain).
Time Frame
Up to 6 months
Title
Quality of life (QOL) - Health outcomes 2
Description
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).
Time Frame
Up to 6 months
Title
7 day point prevalence of tobacco use
Description
7-day point prevalence of tobacco use (i.e., switching) will be measured at follow-ups
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Brasky, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theodore Brasky
Phone
614-293-3772
Email
Theodore.Brasky@osumc.edu
First Name & Middle Initial & Last Name & Degree
Theodore Brasky

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Pilot Trial of E Cigarettes in Pts Diagnosed With Cancer of the Head, Neck, and Lung

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