Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
Stopped early
Conditions studied: Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT01992068
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 5
- Starts
- 2013-09-01
- Expected to finish
- 2016-12-12
- Last updated by the study team
- 2017-04-06
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Department of Radiation Oncology Clinic — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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