Lung CancerNCT01992068
Pilot Study: Utilizing Manometry to Assess Radiation-Induced Changes in Esophageal Function
An observational study of Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Cancer
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 12 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Radiation Oncology Clinic
Chapel Hill, North Carolina, 27599
About this study
Official title: Prospective Pilot Study of High-resolution Manometry to Assess Radiation-induced Changes in Esophageal Function in Patients With Lung Cancer
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.
Read the 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.
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Rate of radiation-induced changes in esophageal function
To estimate the rate of radiation-induced changes in regional esophageal function.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startSep 2013
- Primary completion12 Dec 2016
- Study completion12 Dec 2016
Why it stopped: Closure due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Zagar, MD, Principal investigator, Department of Radiation Oncology, University of North Carolina Chapel HillRyan Madanick, MD, Principal investigator, Department of Medicine, University of North Carolina Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992068
- Sponsor's protocol ID
- LCCC 1309
- Other IDs
- LCCC 1309, 13-1113
- Status last verified
- Apr 2017
- First submitted
- 18 Nov 2013
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of High-resolution Manometry to Assess Radiation-induced Changes in Esophageal Function in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT01992068
- Acronym / sponsor ID
- LCCC 1309
- Conditions
- Lung Cancer
- Keywords
- lung cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closure due to low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 12 Dec 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Rate of radiation-induced changes in esophageal function
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Closure due to low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Zagar, MD principal investigator
Department of Radiation Oncology, University of North Carolina Chapel Hill
Ryan Madanick, MD principal investigator
Department of Medicine, University of North Carolina Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closure due to low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilizing manometry to assess radiation-induced changes to esophageal function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.