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Clinical Trial Summary

Observational (non-drug) study to look at the risks and burden of mucositis (sores) involving the mouth, throat and intestines in patients receiving chemotherapy and radiation therapy treatment for various cancer types.


Clinical Trial Description

This comprehensive, observational study will prospectively elicit the true incidence (risk) and health and economic burdens of mucosal toxicities associated with anti-cancer drug and radiation therapy. This study will examine the burden of illness of gastrointestinal mucositis (defined as mucositis involving the mouth, esophagus, or small intestine) in the most significant regimens used to treat the most common types of cancers. It is an international investigation in which 1600 patients being treated with specific regimens for cancers of the head and neck, breast, colon, lung (NSCLC)and Non-Hogkin's Lymphoma will be prospectively enrolled from centers throughout the US, Canada, Europe and Australia. ;


Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms

  • Gastrointestinal Mucositis (Defined as Mucositis Involving the Mouth, Esophagus, or Small Intestine)
  • Mucositis

NCT number NCT00336609
Study type Observational
Source TRIAD Burden of Illness
Contact Stephen T Sonis, DMD, DMSc.
Phone 617 525-6864
Email ssonis@partners.org
Status Recruiting
Phase N/A
Start date November 2005
Completion date May 2007