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Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

2014-08-27 03:53:58 | BioPortfolio

Summary

The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Dysphagia

Intervention

Palifermin, Placebo

Status

Active, not recruiting

Source

Biovitrum

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:53:58-0400

Clinical Trials [146 Associated Clinical Trials listed on BioPortfolio]

Palifermin for the Reduction of Oral Mucositis in Single-Dose Evaluation (PROMISE)

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health ...

Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults

Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine wheth...

Evaluate PKs and Efficacy Assessment of Palifermin in Patients With Sarcoma

Primary: 1. To evaluate the preliminary efficacy of palifermin in reducing the incidence and severity of oral mucositis (OM) in patients with sarcoma receiving multicycle ...

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma

The purpose of this study is to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologo...

Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support

Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of pali...

PubMed Articles [1073 Associated PubMed Articles listed on BioPortfolio]

Predictors of dysphagia in critically injured patients with neck trauma.

Trauma patients admitted to the intensive care unit (ICU) are at heightened risk for oropharyngeal dysphagia and pulmonary aspiration. Timely and appropriate referrals for dysphagia may reduce mortali...

The Effect of Improved Dysphagia Care on Outcome in Patients with Acute Stroke: Trends from 8-Year Data of a Large Stroke Register.

Early dysphagia screening and appropriate management are recommended by current guidelines to reduce complications and case fatality in acute stroke. However, data on the potential benefit of changes ...

The Impact of Dysphagia on Mortality of Nursing Home Residents: Results From the nutritionDay Project.

Dysphagia is a frequent finding in nursing home residents. The aim of this study is to evaluate the association of dysphagia and mortality in nursing home residents and identify further risk factors f...

Relationship between dysarthria and oral-oropharyngeal dysphagia: The current evidence.

There is a high prevalence of dysphagia among patients with neuromuscular diseases and cerebrovascular diseases, and its consequences can be profound. However, the correlation between dysarthria and o...

Correlation of Patient- and Physician-Scored Dysphagia with Videofluoroscopies in Patients Treated with Radiotherapy for Head and Neck Cancer.

The aim of this study was to investigate the correlation between patient-scored dysphagia and physician-scored dysphagia in head and neck cancer patients treated with radiotherapy. Furthermore, we wan...

Medical and Biotech [MESH] Definitions

Difficulty in SWALLOWING which may result from neuromuscular disorder or mechanical obstruction. Dysphagia is classified into two distinct types: oropharyngeal dysphagia due to malfunction of the PHARYNX and UPPER ESOPHAGEAL SPHINCTER; and esophageal dysphagia due to malfunction of the ESOPHAGUS.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

A hypermotility disorder of the ESOPHAGUS that is characterized by spastic non-peristaltic responses to SWALLOWING; CHEST PAIN; and DYSPHAGIA.

Acute types of coxsackievirus infections or ECHOVIRUS INFECTIONS that usually affect children during the summer and are characterized by vesiculoulcerative lesions on the MUCOUS MEMBRANES of the THROAT; DYSPHAGIA; VOMITING, and FEVER.

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