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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00769652
Other study ID # CDR0000592862
Secondary ID P30CA07272000060
Status Terminated
Phase N/A
First received
Last updated
Start date October 2006
Est. completion date August 2009

Study information

Verified date September 2023
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey

Sponsors (2)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Fat Free Mass (FFM) 3 years
Primary Change in Weight 3 years
Primary Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study 3 years
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