Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
The purpose of this study is to prospectively assess the feasibility of high-resolution manometry to identify radiation-induced changes in esophageal motility and contractility or "function" in patients undergoing radiation therapy for the treatment of locally advanced lung cancer.
Checked against the public recordLast updated Apr 6, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Interventions being studied
- Not specified
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Age ≥ 18 years or older * Absence of any severe disorders of esophageal motility (patients with reflux and/or a hiatal hernia are eligible) * Histologically confirmed lung cancer scheduled to undergo conventionally fractionated radiation treatment * Patients that will be treated with a minimum of 45 Gy of radiation therapy * Patients with mediastinal nodal disease, or primary lesions that are near the esophagus are eligible provided that they are not having esophageal symptoms believed to be due to the tumor. Exclusion Criteria: * History of esophageal motility disorder that pre-dates and is unrelated to the present diagnosis of lung cancer * History of any prior radiotherapy to the esophagus * Pregnant or lactating women * Inability to understand and follow swallowing instructions for the esophageal manometry procedure; this is to ensure patient compliance of performing the breath hold technique throughout the radiation therapy treatment * Patients with mediastinal nodal disease, or primary lesions, that are having esophageal symptoms believed to be due to the tumor
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Department of Radiation Oncology ClinicChapel Hill, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 6, 2017. Always confirm current availability with the study team.