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

NCT ID: NCT01992068

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-12-12

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Lung cancer patients ≥ 18 years of age

Lung cancer patients age ≥ 18 years or older who have:

• Histologically confirmed lung cancer scheduled to undergo conventionally fractionated radiation treatment
• Absence of any severe disorders of esophageal motility (patients with reflux and/or a hiatal hernia are eligible)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy Zagar, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, University of North Carolina Chapel Hill

Ryan Madanick, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, University of North Carolina Chapel Hill

Locations

Department of Radiation Oncology Clinic

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

LCCC 1309

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13-1113

Identifier Type: OTHER

Identifier Source: secondary_id

LCCC 1309

Identifier Type: -

Identifier Source: org_study_id