Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer
Primary Purpose
Lung Cancer, Malnutrition, Pancreatic Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medical nutrition therapy
Standard Care
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring malnutrition, non-small cell lung cancer, small cell lung cancer, stage III prostate cancer, stage IV prostate cancer, pancreatic cancer, weight changes
Eligibility Criteria
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
Sites / Locations
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medical nutrition therapy
Standard care
Arm Description
Medical nutrition therapy
Standard care
Outcomes
Primary Outcome Measures
Change in Fat Free Mass (FFM)
Change in Weight
Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study
Secondary Outcome Measures
Full Information
NCT ID
NCT00769652
First Posted
October 8, 2008
Last Updated
September 14, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00769652
Brief Title
Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Malnutrition, Pancreatic Cancer, Prostate Cancer, Weight Changes
Keywords
malnutrition, non-small cell lung cancer, small cell lung cancer, stage III prostate cancer, stage IV prostate cancer, pancreatic cancer, weight changes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical nutrition therapy
Arm Type
Experimental
Arm Description
Medical nutrition therapy
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard care
Intervention Type
Behavioral
Intervention Name(s)
Medical nutrition therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
Primary Outcome Measure Information:
Title
Change in Fat Free Mass (FFM)
Time Frame
3 years
Title
Change in Weight
Time Frame
3 years
Title
Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Huhmann, DCN, RD, CSO
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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