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

September 14, 2023 updated by: Rutgers, The State University of New Jersey

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical nutrition therapy
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.
Active Comparator: Standard care
Behavioral: Standard Care
Standard nutritional care includes the National Cancer Institute's booklet "Eating Hints for cancer patients: before, during & after treatment".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Fat Free Mass (FFM)
Time Frame: 3 years
3 years
Change in Weight
Time Frame: 3 years
3 years
Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Maureen Huhmann, DCN, RD, CSO, Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimated)

October 9, 2008

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000592862
  • P30CA072720 (U.S. NIH Grant/Contract)
  • 000605 (Other Identifier: CINJ)
  • 0220060217 (Other Identifier: UMDNJ IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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