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2006-10
2009-08
2009-08
8
NCT00769652
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
INTERVENTIONAL
Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer
This is a two-part study. Part I is an observational study. Part II is a randomized clinical trial to see how well medical nutrition therapy works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.
In Part II of the study, patients are stratified according to tumor type (pancreatic vs lung vs prostate). Patients are then randomized to 1 of 2 arms. * Arm I (Medical nutrition therapy): intervention with a registered dietitian or nutrition professional. MNT is a cyclical process which includes nutrition assessment, intervention, follow-up, and reassessment. Patients will receive a total of three (3) visits with the dietitian over a six-week period with follow-up during weeks 2-3 and weeks 6-9 based on their treatment schedule. * Arm II (standard care): Standard nutritional care includes the National Cancer Institute's booklet ⋪ting Hints for cancer patients: before, during & after treatment". In both arms, patients' weight, fat free mass, and Patient Generated Subjective Global Assessment Score (PG-SGA) score will be assessed before, during, and after the intervention. The PG-SGA includes a patient report of symptoms and a healthcare professional assessment of medical, metabolic, and physical parameters.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2008-10-08 | 2013-11-15 | 2023-09-14 |
2008-10-08 | 2013-11-15 | 2023-10-03 |
2008-10-09 | 2014-01-07 | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Medical nutrition therapy Medical nutrition therapy | BEHAVIORAL: Medical nutrition therapy
|
| ACTIVE_COMPARATOR: Standard care Standard care | BEHAVIORAL: Standard Care
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Change in Fat Free Mass (FFM) | 3 years | |
| Change in Weight | 3 years | |
| Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study | 3 years |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
