Clinical trial NCT01992068: Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
Official title: Prospective Pilot Study of High-resolution Manometry to Assess Radiation-induced Changes in Esophageal Function in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Utilizing manometry to assess radiation-induced changes to esophageal function
timeFrame: 6 months
Secondary outcomes:
measure: Rate of radiation-induced changes in esophageal function
timeFrame: 6 months
Other outcomes:
measure: Associated changes in esophageal function: manometry versus the Mayo Dysphagia questionnaire
timeFrame: 6 months
Locations:
city: Chapel Hill
country: United States
facility: Department of Radiation Oncology Clinic
state: North Carolina
Study officials:
affiliation: Department of Radiation Oncology, University of North Carolina Chapel Hill
name: Timothy Zagar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Medicine, University of North Carolina Chapel Hill
name: Ryan Madanick, MD
role: PRINCIPAL_INVESTIGATOR
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