Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function

Terminated

• Conditions: Lung Cancer

• Registration Number: NCT01992068
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Utilizing manometry to assess radiation-induced changes to esophageal function	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.

Secondary Outcome Measures

Name	Time	Method
Rate of radiation-induced changes in esophageal function	6 months	To estimate the rate of radiation-induced changes in regional esophageal function.

Trial Locations

Locations (1)

Department of Radiation Oncology Clinic; 🇺🇸 Chapel Hill, North Carolina, United States