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

Prospective Pilot Study of High-resolution Manometry to Assess Radiation-induced Changes in Esophageal Function in Patients With Lung Cancer

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.

Study Overview

• Status: Terminated
• Conditions: 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 Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Department of Radiation Oncology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients age 18 or above who have a histologically confirmed lung cancer diagnosis and are scheduled to undergo conventionally fractionated radiation treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilizing manometry to assess radiation-induced changes to esophageal function	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of radiation-induced changes in esophageal function	To estimate the rate of radiation-induced changes in regional esophageal function.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associated changes in esophageal function: manometry versus the Mayo Dysphagia questionnaire	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	6 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 12, 2016

Study Registration Dates

• First Submitted: November 18, 2013
• First Submitted That Met QC Criteria: November 18, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LCCC 1309 (Other Grant/Funding Number: Lineberger Comprehensive Cancer Center); 13-1113 (Other Identifier: UNC IRB)