Clinical trial · Observational
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
NCT01992068CI-TRIAL-00026815terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closure due to low accrual
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Lung cancer patients ≥ 18 years of age
- description
- 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 outcomes (1)
- measure
- Utilizing manometry to assess radiation-induced changes to esophageal function
- timeFrame
- 6 months
- description
- 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 outcomes (1)
- measure
- Rate of radiation-induced changes in esophageal function
- timeFrame
- 6 months
- description
- To estimate the rate of radiation-induced changes in regional esophageal function.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.