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

NCT01992068 | Terminated DMC

• 2 other identifiers: LCCC 130913-1113
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of radiation-induced changes in esophageal function

  6 months

Other Outcomes (1)

• Associated changes in esophageal function: manometry versus the Mayo Dysphagia questionnaire

  6 months

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Department of Radiation Oncology Clinic

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: November 25, 2013
• Study Start: September 1, 2013
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (1)