NCT00769652

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

January 7, 2014

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

October 8, 2008

Results QC Date

November 15, 2013

Last Update Submit

September 14, 2023

Conditions

Lung CancerMalnutritionPancreatic CancerProstate CancerWeight Changes

Keywords

malnutritionnon-small cell lung cancersmall cell lung cancerstage III prostate cancerstage IV prostate cancerpancreatic cancerweight changes

Outcome Measures

Primary Outcomes (3)

  • Change in Fat Free Mass (FFM)

    3 years

  • Change in Weight

    3 years

  • Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study

    3 years

Study Arms (2)

Medical nutrition therapy

EXPERIMENTAL

Medical nutrition therapy

Behavioral: Medical nutrition therapy

Standard care

ACTIVE COMPARATOR

Standard care

Behavioral: Standard Care

Interventions

Medical nutrition therapyBEHAVIORAL

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.

Medical nutrition therapy
Standard CareBEHAVIORAL

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

Standard care

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsMalnutritionPancreatic NeoplasmsProstatic NeoplasmsBody Weight ChangesCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

Nutrition TherapyStandard of Care

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic DiseasesDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Results Point of Contact

Title
Dr. Elizabeth Poplin, MD (sub-investigator)
Organization
Rutgers Cancer Institute of New Jersey
poplinea@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
732-235-8675

Study Officials

  • Maureen Huhmann, DCN, RD, CSO

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

October 1, 2006

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 3, 2023

Results First Posted

January 7, 2014

Record last verified: 2023-09

Locations

US(1)