Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Respiratory System Agents

All Drugs and Chemicals

Expectorants

Anti-Asthmatic Agents

\[Control group\] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary and regular rehabilitation-propaganda; postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time) and early ambulation unless serious patients.

\[Study group\] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary, regular rehabilitation-propaganda and interventional pulmonary rehabilitation (preoperative part); postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time), early ambulation unless serious patients and interventional pulmonary rehabilitation (postoperative part).

pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations).

pulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations).

pulmonary rehabilitation

Ding-Pei Han, master

He-Cheng Li, doctor

Run-Sen Jin, doctor

Ya-Jie Zhang, doctor

Jie Xiang, bachelor

Kai Chen, master

Hai-Lei Du, master

Jia-Ming Che, bachelor

Jun-Biao Hang, bachelor

Liang-Gang Zhu, master

Xiao-Qing Yang, master

Xiang Zhou, master

Jian Ren, bachelor

It is reported that smoker patients (\>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied. The purpose of this study is to determine whether pulmonary rehabilitation is effective to smoker patients who underwent lobectomy.

In China, the smoker population is about 300 hundred million. Tobacco has become one of the world's public health problem. 30 percent of global surgery patients have smoking history. It is reported that smoker patients (\>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy (38.2% vs 12.5%). Smoking is an independent risk factor of postoperative complications of cardiothoracic surgery. Evidences showed that smoking had a negative effect on airway management which plays an important role in postoperative recovery for thoracic surgery. Therefore, we hypothesise that intervention-related study to find a way to reduce postoperative complications for smoker patients is significantly meaningful in improving the overall outcome after pulmonary surgery as 80 percent of patients with lung cancer are smoker in China. Recently, a series of strategies on airway management have been proposed by clinical doctors. As one of the important parts of airway management, pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the pulmonary complications after thoracic surgery and increase the breathing capacity. According to the reported literatures, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied, so we designed this randomized controlled trial to determine whether pulmonary rehabilitation would be effective to smoker patients who underwent lobectomy which was associated with significant loss of lung function.

According to the reported papers in China, main observation index in experimental group was about 25.7, and in control group was about 10%. At the level of α=0.05 (Bilateral), power of test (1-β)=0.80, ratio=1:1. The estimated minimum required sample size of each group was 93 cases, the statistical loss rate was set as 10%. The overall sample size of this study was about 200 cases.

Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer

Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer

Ruijin Hospital

Professor

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Amino Acids

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.

Patients who have had at least a minor response to gefitinib therapy preoperatively (\> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.

Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy.

Naiyer Rizvi, MD

The purpose of this research study is to:

* see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
* see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
* see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
* see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment.
* see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

This is a phase II, single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene. The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable.

Patients must have 1 or more of the following features: never smoker or smoking history of \< 15 pack years and/or features of bronchioloalveolar lung cancer. 50 patients will be enrolled on this study. Treatment will be with gefitinib for at least 21 days before surgery (depending on the timing of the surgery). Patients will discontinue gefitinib 2 days before their operation. For patients that demonstrate a radiographic response to gefitinib preoperatively and /or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene (identified from the surgical sample), gefitinib will continue for 2 years post-surgery. Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study.

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC

Radiographic response is defined as a minor response ( \> 25% decrease in the sum of the products of measured lesions)

Each patient provides two binary variables: presence/absence of mutation and responder/non responder. The association between the two will be tested using the Fisher's exact test for the resulting 2x2 table.Changes in expression levels within a patient will be assessed using a paired t-test. Similarly differences in expression levels between responders and non-responders will be assessed using a two-sample t-test. Appropriate adjustment will be made for the multiple comparisons problem that arises because there are over 21,000 probe sets on the U133A array.

Memorial Sloan Kettering Cancer Center

Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.

Patients who have had at least a minor response to gefitinib therapy preoperatively (\> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.

Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy.

Treatment

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Charles Rudin

The Radiographic Response to Gefitinib

Disease Free Survival

Overall Survival

Tumor specimens analyzed for EGFR mutation

EGFR Mutation Positive

EGFR Mutation Negative

Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data

Overall Study

Digestive System Diseases

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Smoker and Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy

Non-Smoker and Non-Drinker with Esophageal Squamous Cell Carcinoma after Esophagectomy

No intervention

Lin Peng

Xuefeng Leng

Lin Peng, M.D.

Wenwu He, M.D.

Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank

Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy

Long-term Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy

Overall Survival was calculated from the month and year of surgery to the time of death or last follow-up in April 2024

Sichuan Cancer Hospital and Research Institute

Behaviors and Mental Disorders

Small Cell Lung Carcinoma

Small Cell Lung Cancer

Quality of Life

Individuals who have been diagnosed with lung cancer. Individuals with all stages of lung cancer and individuals who have reached no evidence of disease (NED).

Family and friends who provide care for someone who has been diagnosed with lung cancer

There are no interventions in this study. All participants complete online surveys.

Tracey Grant, MS

Bellinda King-Kallimanis, PhD

Upal Basu Roy, PhD, MPH

LUNGevity Foundation, a non-profit lung cancer organization, wants to learn about living with lung cancer from the point of view of people with lung cancer and their family and friends who provide care. To do this, we have an online study designed to better understand how treatments people living with lung cancer receive impact their quality of life. Participants will complete surveys once a month for 12 months.

What does participation involve?

1. Emailing the study team to learn more and get access to the study website.
2. Once a month for 12 months you will receive a survey by email.
3. Complete these surveys on a smartphone, tablet, or computer at your convenience and receive an e-gift card for your time.

PEER is an international study, that is Institutional Review Board (IRB) approved and General Data Protection Regulation (GDPR) compliant.

The study objective is to collect longitudinal data to facilitate a rigorous understanding of the diagnostic and treatment experiences of people diagnosed with lung cancer and to identify determinants of treatment heterogeneity. Study data will be used to understand the diagnostic and treatment pathways, explore patient-experience data in different domains (financial impact/quality of life/symptoms) and test the hypothesis that different classes of therapies (chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (eg., physical function).

Study participants will consent and register for the study and complete an initial baseline survey. They will then be followed for 12 months and receive a monthly survey (11 surveys in total) via email. The development of the surveys was guided by input from patients, clinicians, FDA experts, and incorporates questions from existing patient-reported outcomes (PRO) measures.

Summarized study results will also be posted on LUNGevity's website. External researchers will be able to apply to have limited access to de-identified data.

Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting

Exploratory descriptive analyses to understand the concerns participants who enrolled in 2020 and 2021 experienced with respect to their treatment and COVID-19

Patient-reported treatments will be explored in relation to other clinical data provided (e.g., biomarker presence) and the National Comprehensive Cancer Network (NCCN) guidelines for those clinical characteristics at the time of treatment.

Patterns based on disease staging and treatment class will be explored using the European Organisation for Research and Treatment of Cancer Quality of Life 30-item questionnaire (EORTC QLQ-C30), the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), and a side effect questionnaire to explore these patient-reported outcomes.

Scores for the EORTC QLQ-C30 are transformed so that for each subscale the range is 0-100. For functioning subscales, higher scores indicate better functioning, and for symptoms higher scores indicate more symptom burden. Scores for the NSCLC-SAQ range from 0-20, with higher scores indicating more severe symptomology.

Test whether different classes of therapies (e.g., chemotherapy/ immunotherapy/ targeted therapy/ surgery/ radiation) impact patient experience (e.g., side effects, functioning). Both within and between patient experiences will be investigated. Results from Project PEER will be compared currently existing clinical trial data.

Amgen

AstraZeneca

Blueprint Medicines Corporation

Boehringer Ingelheim

Bristol-Myers Squibb

Eli Lilly and Company

G1 Therapeutics, Inc.

Genentech, Inc.

Janssen, LP

Jazz Pharmaceuticals

Merck Sharp & Dohme LLC

Novartis

Takeda

LUNGevity Foundation

This study is an observational study. There is no intervention.

Biomarker (not used as an intervention)

Duncan Whitney, PhD

The purpose of the research study is to develop a new, more sensitive, and less invasive test for diagnosing lung cancer at an earlier stage, when it can more easily be cured. The investigators hypothesize that certain genes are expressed differently in current and former smokers who have lung cancer, and this difference in gene expression may be a biomarker for lung cancer.

Allegro Diagnostics is funding this multi-center study to validate and extend a new diagnostic tool measuring global gene expression in airway epithelial cells obtained at routine bronchoscopy in suspect lung cancer patients. The test, which is highly sensitive and specific for lung cancer, measures the levels of expression of genes in cells brushed from the large bronchi during diagnostic bronchoscopy. Similar brushings of epithelial cells from the nose will be analyzed to determine if gene expression in these cells can be used as a screening tool in subjects who may have now or be at risk for developing lung cancer in the future.

Airway Epithelium Gene Expression: AEGIS IDE

Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS IDE

Patients may be followed at 12 months post bronchoscopy to finalize diagnosis if diagnosis had not previously been confirmed. The biomarker score will be compared to the standard diagnosis to evaluate the sensitivity, specificity, and negative predictive values of the biomarker.

University of Pennsylvania

Columbia University

Temple University

Indiana University

University of Alabama at Birmingham

University of Missouri-Columbia

Louisiana State University Health Sciences Center in New Orleans

University of Wisconsin, Madison

Medical University of South Carolina

National Jewish Health

Overlake Hospital Bellevue WA

Pulmonary and Allergy Associates of New Jersey

Pulmonary Associates of Arizona

William Jennings Bryan Dorn VA Medical Center

Virginia Commonwealth University

Jamaica Hospital Medical Center

North Florida/South Georgia Veterans Health System

Steward St. Elizabeth's Medical Center of Boston, Inc.

University of California, Davis

Yale University

The Cleveland Clinic

Allegro Diagnostics, Corp.

Phenylalanine

All subjects are given 1 microgram \[D10\]phe before and after consuming Brussels sprouts once daily for 7 consecutive days.

Subjects are given \~150 g of Brussels sprouts once daily for 7 consecutive days.

Brussel Sprouts

Subjects are given 1 microgram of deuterated phenanthrene \[D10\]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.

Deuterated Phenanthrene

Naomi Fujioka, MD

To determine whether glucobrassicin-rich Brussels sprouts can favorably modify the metabolism of the polycyclic aromatic hydrocarbon deuterated phenanthrene (\[D10\]phe) in current and former smokers

Subjects will be given 1 microgram of \[D10\]phe, and all urine will be collected for 6 h afterwards to quantify baseline levels of \[D10\]phenanthrene tetraol (\[D10\]pheT) and \[D10\]phenanthrols (\[D10\]HOP). Within 3 days of this baseline measurement, subjects will consume 200 micromoles of glucobrassicin in the form of raw Brussels sprouts (\~200-300 grams) at the study center once daily for 7 consecutive days. Urine will be collected for 24 h after vegetable consumption on days 3 ± 1 and 6 of the feeding intervention for 3,3'-diindolylmethane (DIM) quantification. On day 7 of the feeding intervention, a second dose of 1 microgram of \[D10\]phe will be administered at the study center after vegetable consumption, followed by another 6 h urine collection.

Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism

Assessing the Effect of Glucobrassicin-Rich Brussels Sprouts on the Metabolism of Deuterated Phenanthrene: Developing Food-Based Chemoprevention of Tobacco-Related Lung Cancer

Urinary DIM will be quantified after Brussels sprout consumption on day 3 and day 6 of the feeding intervention for urinary DIM quantification

Compare level of urinary \[D10\]phenanthrene tetraol before and after 7 days of Brussels sprout consumption.

Compare level of urinary \[D10\]phenanthrene phenanthrols before and after 7 days of Brussels sprout consumption.

Masonic Cancer Center, University of Minnesota

Web intervention- and access to pharmacotherapy

Receives tailored print materials and access to pharmacotherapy (Materials condition)

Receives pharmacotherapy and access to an interactive Web site (Web condition). The Web site will offer tailored intervention messages and strategies in an interactive format that is much less labor-intensive and costly than the prior PFH peer telephone counseling intervention.

Web Intervention

tailored print materials designed to aid in smoking reduction and cessation

print materials

Karen M Emmons, PhD

The purpose of this study was to compare two different ways of helping people who have had childhood cancer, leukemia, tumors or similar illnesses learn health information and information about trying to quit smoking. All participants received materials in the mail about their health, survivorship, and smoking. Some participants were also invited to use a website. The goal of the study was to see which is a better way to get information about health issues, survivorship, and smoking.

The study was a randomized controlled trial with two groups. It was designed to demonstrate the efficacy and cost-effectiveness of a Web-based format of the PFH intervention, compared to a written Materials control condition. The study was conducted among childhood and young adult cancer survivors, who smoke, at four survivor clinics. Participants in both conditions received access to pharmacotherapy at no cost. Participants in the Web condition received access to an interactive Web site that focuses on survivorship, health, and smoking.

Participants in the Web condition received access to an interactive Web site that focuses on survivorship, health, and smoking. Participants in the Materials control group received tailored and targeted print materials.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer	NCT03010033	Pulmonary Neopl...	pulmonary rehab...	- 80 Years	Ruijin Hospital
Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene	NCT00588445	Lung Cancer Non-small Cell ... Bronchioloalveo...	Gefitinib	18 Years -	Memorial Sloan Kettering Cancer Center
Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy	NCT06269341	Outcomes of Smo...	No intervention	18 Years - 90 Years	Sichuan Cancer Hospital and Research Institute
Project PEER: Understanding the Lung Cancer Patient ExperiEnce in the Real-World Setting	NCT05826756	Lung Cancer Pat... Caregivers	There are no in...	18 Years -	LUNGevity Foundation
Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy	NCT06269341	Outcomes of Smo...	No intervention	18 Years - 90 Years	Sichuan Cancer Hospital and Research Institute
Airway Epithelium Gene Expression: AEGIS IDE	NCT00746759	Lung Cancer	Biomarker (not ...	21 Years -	Allegro Diagnostics, Corp.
Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer	NCT03010033	Pulmonary Neopl...	pulmonary rehab...	- 80 Years	Ruijin Hospital
Glucobrassicin-Brussel Sprout Effect on D10 Phe Metabolism	NCT02999399	Smoking	Brussel Sprouts Deuterated Phen...	18 Years - 99 Years	Masonic Cancer Center, University of Minnesota
A Web Site and Print Materials Intervention for Smoking Intervention for Childhood and Young Adult Cancer Survivors	NCT00588107	Cancer	Web Interventio... print materials	18 Years - 55 Years	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for smoker

Every month we try and update this database with for smoker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for smoker

Every month we try and update this database with for smoker cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for smoker cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.