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

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00769652
First received: October 8, 2008
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Lung Cancer
Malnutrition
Pancreatic Cancer
Prostate Cancer
Weight Changes
Interventions: Behavioral: Medical nutrition therapy
Behavioral: Standard Care

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eight subjects were enrolled from October 2006 through May 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1 subject was consented but did not get randomized.

Reporting Groups
  Description
Medical Nutrition Therapy

Medical nutrition therapy

Medical nutrition therapy : 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.

Standard Care

Standard care

Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".


Participant Flow:   Overall Study
    Medical Nutrition Therapy     Standard Care  
STARTED     6     1  
COMPLETED     6     1  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Medical Nutrition Therapy

Medical nutrition therapy

Medical nutrition therapy : 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.

Standard Care

Standard care

Standard Care : Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".

Total Total of all reporting groups

Baseline Measures
    Medical Nutrition Therapy     Standard Care     Total  
Number of Participants  
[units: participants]
  6     1     7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     1     5  
>=65 years     2     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  61  ± 4.9     60     60.9  ± 4.5  
Gender  
[units: participants]
     
Female     1     0     1  
Male     5     1     6  
Region of Enrollment  
[units: participants]
     
United States     6     1     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Fat Free Mass (FFM)   [ Time Frame: 3 years ]

2.  Primary:   Change in Weight   [ Time Frame: 3 years ]

3.  Primary:   Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Elizabeth Poplin, MD (sub-investigator)
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: poplinea@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu


No publications provided


Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00769652     History of Changes
Other Study ID Numbers: CDR0000592862, P30CA072720, 000605, 0220060217
Study First Received: October 8, 2008
Results First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: United States: Institutional Review Board