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

October 8, 2008
November 15, 2013
October 2006
August 2009   (final data collection date for primary outcome measure)
  • Change in Fat Free Mass (FFM) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in Weight [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Percentage of lean body mass at time of initial presentation and throughout study [ Designated as safety issue: No ]
  • Weight at 3, 6, 12, 18, 24, 30, and 36 months [ Designated as safety issue: No ]
  • Patient Generated Subjective Global Assessment score at time of initial presentation and throughout study [ Designated as safety issue: No ]
  • Quality of life at 3, 6, 12, 18, 24, 30, and 36 months as measured by the Functional Assessment of Cancer Therapy-General questionnaire [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00769652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer
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

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 "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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Lung Cancer
  • Malnutrition
  • Pancreatic Cancer
  • Prostate Cancer
  • Weight Changes
  • Behavioral: 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.
  • Behavioral: Standard Care
    Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".
  • Experimental: Medical nutrition therapy
    Medical nutrition therapy
    Intervention: Behavioral: Medical nutrition therapy
  • Active Comparator: Standard care
    Standard care
    Intervention: Behavioral: Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00769652
CDR0000592862, P30CA072720, 000605, 0220060217
No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Maureen Huhmann, DCN, RD, CSO Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP