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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 [125 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 ...

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...

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...

PubMed Articles [992 Associated PubMed Articles listed on BioPortfolio]

Structural cause of dysphagia detected during videofluoroscopic swallow study.

Dysphagia can be caused by many different underlying conditions. The assessment and management of dysphagia depend on each individual patient, often requiring a multidisciplinary approach. Structural ...

Effects of Capsaicin on Older Patients with Oropharyngeal Dysphagia: A Double-Blind, Placebo-Controlled, Crossover Study.

The standard of care for older patients with oropharyngeal dysphagia (OD) is poor. Stimulation of transient receptor potential vanilloid 1 might become a pharmacological strategy for these patients. T...

Cognitive impairment has no impact on hospital-associated dysphagia in aspiration pneumonia patients.

Hospital-associated dysphagia, characterized by deconditioning of swallowing as a result of hospitalization, is sometimes observed in patients with aspiration pneumonia (AP). Cognitive impairment is k...

Randomized Placebo-Controlled Placebo Trial to Determine the Placebo Effect Size.

It is the gold standard to use a placebo treatment as the control group in prospective randomized controlled trials (RCTs). Although placebo-controlled trials can reveal an effect of an active treatme...

European Society for Swallowing Disorders FEES Accreditation Program for Neurogenic and Geriatric Oropharyngeal Dysphagia.

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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