Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Eating 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.

Official Title
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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

Conditions
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Lung Cancer, Malnutrition, Pancreatic Cancer, Prostate Cancer, Weight Changes

Intervention / Treatment
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* Behavioral: Medical nutrition therapy
* Behavioral: Standard Care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosed with one of the following: Pancreatic cancer Lung cancer Stage III or IV prostate cancer Undergoing treatment at The Cancer Institute of New Jersey Are undergoing chemotherapy (part 2 only) Has lost ≥ 5% of their usual body weight in the previous 6 months (part 2 only) PATIENT CHARACTERISTICS: Life expectancy > 60 days Must speak and read English Accessible in person or by phone for completing questionnaires Not pregnant or nursing PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical nutrition therapy<br>Medical nutrition therapy | Behavioral: Medical nutrition therapy<br>* Medical nutrition therapy (MNT) refers to 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.<br>|
| Active Comparator: Standard care<br>Standard care | Behavioral: Standard Care<br>* Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, non-small cell lung cancer, small cell lung cancer, stage III prostate cancer, stage IV prostate cancer, pancreatic cancer, weight changes