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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of radiation-induced changes in esophageal function [ Time Frame: 6 months ]
    To estimate the rate of radiation-induced changes in regional esophageal function.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Department of Radiation Oncology Clinic
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
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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
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01992068    
Other Study ID Numbers: LCCC 1309
LCCC 1309 ( Other Grant/Funding Number: Lineberger Comprehensive Cancer Center )
13-1113 ( Other Identifier: UNC IRB )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases