Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer
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| First Received Date ICMJE | October 8, 2008 | ||||
| Last Updated Date | December 10, 2009 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00769652 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer | ||||
| Official Title ICMJE | The Influence of Changes in Body Composition on Quality of Life in Cancer Patients and The Impact of Medical Nutrition Therapy by a Registered Dietitian on Outcome | ||||
| Brief Summary | RATIONALE: Gathering information about changes in weight and body composition over time in patients with cancer may help doctors learn more about medical nutrition therapy and quality of life. PURPOSE: This randomized clinical trial is studying medical nutrition therapy to see how well it works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a two-part study.
In both arms, patients' weight, quality of life, and body composition are measured using the Functional Assessment of Cancer Therapy-General (FACT-G), the Symptom Distress Scale (SDS), ECOG performance status, BIA, and PG-SGA score. All patients receive the National Cancer Institute's booklet "Eating Hints for Cancer Patients: Before, During & After Treatment." |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 230 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00769652 | ||||
| Other Study ID Numbers ICMJE | CDR0000592862, P30CA072720, CINJ-000605, CINJ-IRB-0220060217 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Maureen Huhmann, UMDNJ/CINJ | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Medicine and Dentistry New Jersey | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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