Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
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|ClinicalTrials.gov Identifier: NCT01992068|
Recruitment Status : Terminated (Closure due to low accrual)
First Posted : November 25, 2013
Last Update Posted : April 6, 2017
|Condition or disease|
As there is no standard of care to evaluate/visualize the effects of radiation therapy (RT) -induced esophageal injury, this is routinely assessed by patient reported accounts, and the symptoms are then managed supportively (e.g. with pain medicines, parenteral nutrition, feeding tubes etc). Manometry has been frequently used to study the effects of RT on gastrointestinal function in the setting of numerous malignancies, including colorectal, cervical and prostate cancers. What is often seen after RT is decreased sphincter function in the anorectal region leading to problems with continence and fecal urgency, however there has not been as rigorous of an evaluation of esophageal function after RT.
One study performed more than 15 years ago included only 4 patients with lung cancer and concluded that mucosal irritation was likely the primary cause of RT-associated esophageal injury and no abnormalities in motility were seen. Radiation is known to cause long-term esophageal injury including stricture, and there is manometric evidence of impaired motility long-term after RT. The recent introduction of high-resolution manometry permits more extensive evaluation of the effects of RT on esophageal function.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Prospective Pilot Study of High-resolution Manometry to Assess Radiation-induced Changes in Esophageal Function in Patients With Lung Cancer|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 12, 2016|
|Actual Study Completion Date :||December 12, 2016|
Lung cancer patients ≥ 18 years of age
Lung cancer patients age ≥ 18 years or older who have:
- Utilizing manometry to assess radiation-induced changes to esophageal function [ Time Frame: 6 months ]To evaluate the feasibility of high-resolution manometry to identify radiation-induced changes in esophageal function in patients undergoing radiation therapy for the treatment of locally advanced lung cancer.
- Rate of radiation-induced changes in esophageal function [ Time Frame: 6 months ]To estimate the rate of radiation-induced changes in regional esophageal function.
- Associated changes in esophageal function: manometry versus the Mayo Dysphagia questionnaire [ Time Frame: 6 months ]To explore the association of the changes in regional esophageal function during and after RT with changes in esophageal symptoms as assessed by the Mayo Dysphagia Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992068
|United States, North Carolina|
|Department of Radiation Oncology Clinic|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Timothy Zagar, MD||Department of Radiation Oncology, University of North Carolina Chapel Hill|
|Principal Investigator:||Ryan Madanick, MD||Department of Medicine, University of North Carolina Chapel Hill|