RejuvenAir™ System Lobectomy Safety and Histology Study
Lung NeoplasmsAirway Obstruction1 moreCryotherapy has a long history of safe use in various medical procedures. RejuvenAir System radial spray cryotherapy is a novel procedure being developed as a treatment for conditions associated with abnormal bronchial function, such as chronic bronchitis. The development of appropriate reliable equipment, definition of therapeutic parameters, and an understanding of the tissue effects of treatment have been established through animal studies. This clinical study is being undertaken to assess the feasibility and safety of the application of a radial metered dose spray cryotherapy in the human airway and to evaluate the treatment depth in human airways. The study design is prospective, open label, single arm multi-center study that will consist of up to 15 subjects at up to 3 enrolling sites in Ireland, UK and The Netherlands RejuvenAir System treatment will be performed during preoperative bronchoscopy 0 to 60 days prior to prescheduled lung resection in Subjects requiring lobectomy or pneumonectomy for removal of peripheral tumors. Treatment will be limited to areas of the bronchi within the lobe that will be removed, distal to the anticipated margin of resection. Treatment should be at least 1 cm from the bronchial resection margins and away from the tumor bed. Treated airways will be inspected via bronchoscopy at the time of thoracotomy, and examined histologically following surgical resection. Subject participation will be from 1 to 60 days and enrollment is anticipated to take 4-5 months.Total study duration is expected to last approximately 10 months.
Enhancing Adherence and Knowledge of Erlotinib in Patients Wtih Non-Small Cell Lung Cancer
Lung CancerResearch has found that patients sometimes have trouble obtaining oral (by mouth) cancer medications, understanding how to take these pills, handling side effects related to these drugs, and remembering to take these medications. The purpose of this research study is to have direct care nurses (DCNs) in the Thoracic Oncology Program (TOP) clinic provide teaching and follow-up to patients starting erlotinib (using a teaching tool) and to test the feasibility of providing education and follow-up. This study will also evaluate if increasing knowledge about erlotinib helps participants manage side effects and stay on their erlotinib without interruptions.
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291,...
Advanced Non Small Cell Lung CancerAdvanced (Inoperable) Non Small Cell Lung CancerThis is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy. Part A will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if they and the Investigator deem it appropriate, until such time as their disease progresses, the Investigator believes they are no longer deriving clinical benefit, or they stop taking AZD9291 for any other reason
Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis...
Breast NeoplasmsLung Neoplasms2 moreThe purpose of this study is to evaluate the efficacy of the "Smart Management Strategy for Health (SMASH)" program, which is designed to help cancer patients overcome their cancer crisis proactively and grow positively.
Video-Assisted Intervention in Improving Recovery in Patients With Cancer Undergoing Lung Surgery...
Malignant Lung NeoplasmThis pilot clinical trial studies a video-assisted intervention in improving recovery of patients undergoing surgery to remove lung cancer or cancer that has spread to the lung and their caregivers. The intervention uses educational videos to prepare patients and families for surgery and teach them how to manage the symptoms after surgery. Teaching patients and their families what to expect before and after surgery may help improve patient and caregiver quality of life, help patients recover better from surgery, and support families in their role as caregivers after surgery.
Mindfulness for Lung Cancer Patients and Partners
Lung CancerThe aim of the current study is to examine the (cost)effectiveness of mindfulness based stress reduction (MBSR) in comparison with treatment as usual for patients with lung cancer and their partners.
Feasibility of re Biopsies at Progression
Lung CancerFeasibility of new biological and histological samples at progression in patients with advanced or metastatic Non Small Cell Lung Cancer (NSCLC). A recent paper from Professor Sequist and coll. has depicted the resistance mechanisms as Thréonine790Methionine (T890M) mutation oncogene cMet (CMet) amplification. Re-biopsies showed in 14% of cases the transition between NSCLC to Small Cells Lung Cancer (SCLC). In 3 patients, resistance mechanisms have disappeared and they became again sensitive to Tyrosine Kinase Inhibitors (TKIs). It is mandatory to have a better description to natural history of the disease. This study will be conducted by the French Group of Pneumology-Oncology (Groupe Français de Pneumo Cancérologie (GFPC)) up to 100 patients during 18 Months. Each center will have to define if re-biopsies are possible or not and explain why not.
Study to Determine the Effect of Food on the Blood Levels of AZD9291 Following Oral Dosing of a...
Advanced Non Small Cell Lung CancerAdvanced (Inoperable) Non Small Cell Lung CancerThis is a 2-part study in patients with epidermal growth factor receptor mutation positive (EGFRm+) non-small cell lung cancer (NSCLC) whose disease has progressed on treatment with an epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI): Part A will determine the effect of food on the pharmacokinetics (PK) of AZD9291; Part B will allow patients further access to AZD9291 and will provide for additional safety data collection. Part A is a randomised, open-label, 2 treatment period crossover study in which patients will each receive a single oral dose of AZD9291 (1 x 80 mg tablet) at breakfast time (approximately 0800) in each of 2 treatment periods (once immediately following a high fat meal [fed], and once in the fasted state [fasted]), with a washout period of 9 days between doses. Approximately 38 patients are planned to be enrolled and dosed; at least 30 evaluable patients will be required to complete Part A (ie, the last PK sample in Treatment Period 2 [TP 2] has been collected). Additional patients may be enrolled to allow for at least 30 evaluable patients
Yoga Program for Lung Cancer Patients and Caregivers
Lung CancerThe goal of this behavioral research study is to learn the opinion of patients and their caregivers about a couple-based Hatha Yoga program (Group 1) during treatment for cancer. Researchers also want to learn the effect of this program on lung function, distress, biological function, and quality of life. For comparison purposes, there will also be a group of participants (Group 2) that does not take part in this program. You and your caregiver/family member will have about a 50/50 chance of being assigned to each group. The groups are randomly assigned, but it is also based on other factors such as your age and the status of the disease.
Exercise in Advanced Stage Lung Cancer Patients
Non Small Cell Lung Cancer StageSmall Cell Lung CancerThe aim of this study is to evaluate the effect of twelve weeks of a physical and psycho-social program consisting of: supervised, structured exercise training in a group of advanced lung cancer patients (cardio and strength training, relaxation training) twice weekly. Primary outcome is (VO2peak). The hypotheses are that patients who undergo this intervention will increase maximal oxygen uptake (VO2peak), strength (1RM), functional capacity (6MWD) and quality of life (HRQOL) and reduce the level of anxiety and depression compared to those who do not.