Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Carbon Monoxide

Antimetabolites

Neurotransmitter Agents

Patients undergo bronchoscopy over 30-60 minutes and receive canakinumab SC 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and CO testing on study.

Undergo buccal, nasal, and blood sample collection

Biospecimen Collection

Bronchoscopy

Canakinumab

Carbon Monoxide Measurement

Survey Administration

The Ohio State Comprehensive Cancer Center

Peter G. Shields, MD

Peter G Shields, MD

This phase II trial tests the impact of canakinumab on biologic samples (buccal, nasal, and blood) from former smokers with increased risk of cancer. Canakinumab blocks the activity of a protein called interleukin-1 beta (IL-1b), an agent of the inflammatory system and is used for the treatment of different non-cancer diseases (like auto-inflammatory diseases). Giving canakinumab may block the inflammatory system and could have positive effects to reduce cancer growth.

PRIMARY OBJECTIVE:

I. To compare baseline bronchoscopy biospecimens with samples approximately 70 days after administration of canakinumab (2 doses, approximately 14 days apart) in healthy former smokers.

SECONDARY OBJECTIVE:

I. Determine the impact of IL-1beta inhibition on downstream inflammatory pathways.

OUTLINE:

Patients undergo bronchoscopy over 30-60 minutes on day 7 and receive canakinumab subcutaneously (SC) 60 minutes and 2 weeks after the initial bronchoscopy. Patients undergo an additional bronchoscopy on day 77. Patients undergo buccal, nasal, and blood sample collection and carbon monoxide (CO testing on study).

Evaluation of Canakinumab in High-Risk Former-Smokers

Molecular Studies of Canakinumab in High-Risk Former-Smokers (CANIFS)

Will be assessed by a generalized linear mixed model (GLM) and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

Will be assessed by a GLM and will be employed with measure as the dependent variable, a main effect of baseline vs. follow-up, covariables sex and age, and a random effect for subject.

Will be performed using SPADE to create a global map of cell types present across samples and how the frequency or activation state of each cell type differs between baseline vs. follow-up (single arm). Will assess batch effects and include batch as a co-variable in the models. Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by ribonucleic acid sequence (RNASeq).

Will be assessed by the human magnetic luminex assay on the Luminex platform and inflammatory gene expression by RNASeq.

Peter Shields

Principal Investigator

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Participants receive access to the online WaQi program to practice Tai Chi supervised and home-based over 8 weeks. Participants also receive standard cessation treatment that includes a prescription or recommendation for NRT and CO testing on study.

Participants receive standard cessation treatment that includes a prescription or recommendation for NRT and undergo CO testing on study. Participants also receive an 8-week online Tai Chi self-administered teaching module subscription at the end of the study.

Best Practice

Internet-Based Intervention

Nicotine Replacement

Tai Chi

Ce Shang, PhD

This clinical trial evaluates an online Tai Chi intervention to promote smoking cessation among cancer survivors. Tai chi is a practice that involves a series of slow gentle movements and physical postures, a meditative state of mind, and controlled breathing. It is a gentle form of exercise that can be done while sitting or standing and does not involve any medications or medical procedures. Tai chi originated as an ancient martial art in China. Over the years, it has become more focused on health promotion and rehabilitation. The use of Tai Chi may be beneficial for cancer patients who want to quit smoking.

PRIMARY OBJECTIVE:

I. To assess the feasibility of the Tai Chi intervention to promote smoking cessation among cancer survivors.

SECONDARY OBJECTIVE:

I. Collect preliminary RCT data on the efficacy of our Tai Chi intervention for the potential of scaling up to a more extensive study.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive access to the online WaQi program to practice Tai Chi supervised and home-based over 8 weeks. Participants also receive standard cessation treatment that includes a prescription or recommendation for nicotine replacement therapy (NRT) and undergo carbon monoxide (CO) testing on study.

ARM II: Participants receive standard cessation treatment that includes a prescription or recommendation for NRT and undergo CO testing on study. Participants also receive an 8-week online Tai Chi self-administered teaching module subscription at the end of the study.

Study staff conducting data management and analyses.

Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

A Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors

Will be assessed by the amount of carbon monoxide in a participant's breath using a portable carbon monoxide monitor (iCOquit), which can be plugged into participants' smartphones.

This outcome will be assessed by the participants completing self-administered online survey that includes 12 questions.

This outcome will be assessed by the participants completing a self-administered online survey that includes 14 questions.

This outcome will be assessed by the participants completing self-administered online survey that includes 7 questions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Canakinumab in High-Risk Former-Smokers	NCT06038526	Cigarette Smoki... Lung Carcinoma	Biospecimen Col... Bronchoscopy Canakinumab Carbon Monoxide... Survey Administ...	55 Years - 73 Years	Ohio State University Comprehensive Cancer Center
Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors	NCT05941858	Hematopoietic a... Malignant Solid...	Best Practice Carbon Monoxide... Internet-Based ... Nicotine Replac... Survey Administ... Tai Chi	21 Years -	Ohio State University Comprehensive Cancer Center
Online Tai Chi Intervention to Promote Smoking Cessation Among Cancer Survivors	NCT05941858	Hematopoietic a... Malignant Solid...	Best Practice Carbon Monoxide... Internet-Based ... Nicotine Replac... Survey Administ... Tai Chi	21 Years -	Ohio State University Comprehensive Cancer Center

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