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| ID | Type | Description | Link |
|---|---|---|---|
| LCCC 1309 | Other Grant/Funding Number | Lineberger Comprehensive Cancer Center | |
| 13-1113 | Other Identifier | UNC IRB |
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Closure due to low accrual
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung cancer patients ≥ 18 years of age | Lung cancer patients age ≥ 18 years or older who have:
|
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Lung cancer patients age 18 or above who have a histologically confirmed lung cancer diagnosis and are scheduled to undergo conventionally fractionated radiation treatment.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology Clinic | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |