Clinical trial NCT00769652: 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
Overall status: TERMINATED
Phase: NA
Conditions: 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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-10-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Fat Free Mass (FFM)
timeFrame: 3 years
measure: Change in Weight
timeFrame: 3 years
measure: Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Maureen Huhmann, DCN, RD, CSO
role: PRINCIPAL_INVESTIGATOR
References: