Lung CancerNCT00530205
Effects of Radiation Therapy on the Body in Patients With Stage III Non-Small Cell Lung Cancer
An observational study of Lung Cancer and Malnutrition, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Lung Cancer, Malnutrition, Weight Changes
- What is being tested?
- physiologic testing, questionnaire administration and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to not given
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care center
Who may be able to join
- Must be able to stand without assistance
Who cannot join
- Unable to comply with study requirements
- Native language other than American English
- Pacemaker or implanted defibrillator
- PRIOR CONCURRENT THERAPY:
- Receiving chemotherapy in combination with radiotherapy
- Concurrent megace or steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment
RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment.
PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine energy and protein consumption on an average radiotherapy treatment day using the multiple pass method 24-hour analysis of food recall at baseline and treatment end.
- To compare energy and protein by mouth intake from baseline to treatment end.
- To measure and compare diet quality from baseline to radiotherapy treatment end by Healthy Eating Index (HEI) score.
- To determine lean body mass versus fat mass using a bioelectrical impedance analysis machine.
- To compare body fat to lean body mass percentage at baseline with that at radiotherapy treatment end.
- To correlate energy and protein consumption with lean body mass at baseline and treatment end.
- To determine the change in appetite throughout radiotherapy by comparing data obtained by interview at baseline and radiotherapy treatment end.
- To determine the change in performance level (Karnofsky percentage) associated with the radiotherapy through a series of questions asked at baseline and treatment end.
OUTLINE: Patients receive radiotherapy as planned for 7 weeks. Patients undergo an interview on treatment day 1 (before initiation of radiotherapy) and treatment day 35 (after completion of radiotherapy) regarding recent food consumption history and appetite. Patients' standing weight and height are measured on these days and their body composition, measured with a bioelectrical impedance analysis (BIA) device, are also taken. Patients' Karnofsky performance score are obtained from their medical record.
- Conditions
- Lung Cancer, Malnutrition, Weight Changes
- Being tested
- physiologic testing, questionnaire administration, management of therapy complications, radiation therapy
- Keywords
- weight changes, malnutrition, stage III non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Malnutrition, Body Weight Changes, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiologic testingOther
questionnaire administrationOther
management of therapy complicationsProcedure or surgery
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy and protein consumption measured on an average radiotherapy treatment day by multiple pass method 24-hour analysis for food recall at baseline and treatment end
Comparison of energy and protein by mouth intake from baseline to treatment end
Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end
Lean body mass versus fat mass using a bioelectrical impedance analysis machine
Comparison of body fat to lean body mass percentage at baseline and at treatment end
Correlation of energy and protein consumption with lean body mass at baseline and treatment end
Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment
Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startFeb 2007
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.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jessica Stauffer, BS, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00530205
- Sponsor's protocol ID
- CASE5506
- Other IDs
- P30CA043703, CASE5506, CASE-5506-CC217
- Status last verified
- Jul 2011
- First submitted
- 13 Sep 2007
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation of the Change in Percent Lean Body Mass of Stage III Non-Small Cell Lung Cancer Undergoing Radiation Treatment
- ClinicalTrials.gov ID
- NCT00530205
- Acronym / sponsor ID
- CASE5506
- Conditions
- Lung Cancer, Malnutrition, Weight Changes
- Keywords
- weight changes, malnutrition, stage III non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2007
- First posted
- 17 Sep 2007 (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.
RATIONALE: Learning about the effects of radiation therapy on the body's muscles, organs, and bones in patients with stage III non-small cell lung cancer may help doctors plan the best treatment.
PURPOSE: This clinical trial is studying the effects of radiation therapy on the body in patients with stage III non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine energy and protein consumption on an average radiotherapy treatment day using the multiple pass method 24-hour analysis of food recall at baseline and treatment end.
- To compare energy and protein by mouth intake from baseline to treatment end.
- To measure and compare diet quality from baseline to radiotherapy treatment end by Healthy Eating Index (HEI) score.
- To determine lean body mass versus fat mass using a bioelectrical impedance analysis machine.
- To compare body fat to lean body mass percentage at baseline with that at radiotherapy treatment end.
- To correlate energy and protein consumption with lean body mass at baseline and treatment end.
- To determine the change in appetite throughout radiotherapy by comparing data obtained by interview at baseline and radiotherapy treatment end.
- To determine the change in performance level (Karnofsky percentage) associated with the radiotherapy through a series of questions asked at baseline and treatment end.
OUTLINE: Patients receive radiotherapy as planned for 7 weeks. Patients undergo an interview on treatment day 1 (before initiation of radiotherapy) and treatment day 35 (after completion of radiotherapy) regarding recent food consumption history and appetite. Patients' standing weight and height are measured on these days and their body composition, measured with a bioelectrical impedance analysis (BIA) device, are also taken. Patients' Karnofsky performance score are obtained from their medical record.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care center
Key inclusion criteria (1 listed)
- Must be able to stand without assistance
Key exclusion criteria (6 listed)
- Unable to comply with study requirements
- Native language other than American English
- Pacemaker or implanted defibrillator
- Receiving chemotherapy in combination with radiotherapy
- Concurrent megace or steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiologic testing | Other | – |
| questionnaire administration | Other | – |
| management of therapy complications | Procedure or surgery | – |
| radiation therapy | Radiation | – |
Primary outcome
Energy and protein consumption measured on an average radiotherapy treatment day by multiple pass method 24-hour analysis for food recall at baseline and treatment end
Comparison of energy and protein by mouth intake from baseline to treatment end
Comparison of diet quality as measured by Healthy Eating Index (HEI) score from baseline to treatment end
Lean body mass versus fat mass using a bioelectrical impedance analysis machine
Comparison of body fat to lean body mass percentage at baseline and at treatment end
Correlation of energy and protein consumption with lean body mass at baseline and treatment end
Change in appetite throughout radiotherapy determined by interview at baseline and end of treatment
Change in performance level (Karnofsky percentage) associated with the radiotherapy procedure determined by questions asked at baseline and end of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2011.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Jessica Stauffer, BS study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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 and Malnutrition, run by Case 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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Jul 2011. 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 withdrawn before enrolling participants, so there are no results.
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?
Energy and protein consumption measured on an average radiotherapy treatment day by multiple pass method 24-hour analysis for food recall at baseline and treatment end. The study lists 8 primary outcomes in all. 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 14 Jul 2011.