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:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00769652
First received: October 8, 2008
Last updated: December 10, 2009
Last verified: December 2009

October 8, 2008
December 10, 2009
October 2006
August 2009   (final data collection date for primary outcome measure)
  • Weight at 3, 6, 12, 18, 24, 30, and 36 months [ 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 ]
  • Percentage of lean body mass at time of initial presentation and throughout study [ Designated as safety issue: No ]
  • Patient Generated Subjective Global Assessment score at time of initial presentation and throughout study [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769652 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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

RATIONALE: Gathering information about changes in weight and body composition over time in patients with cancer may help doctors learn more about medical nutrition therapy and quality of life.

PURPOSE: This randomized clinical trial is studying medical nutrition therapy to see how well it works compared with standard care in treating patients with lung cancer, pancreatic cancer, or stage III or stage IV prostate cancer.

OBJECTIVES:

Primary

  • To describe the relationship between changes in body composition in cancer patients and quality of life (QOL) as measured by Functional Assessment of Cancer Therapy-General (FACT-G), Symptom Distress Scale, and ECOG performance status. (Part 1)
  • To measure clinical (lean body mass, weight, Patient Generated Subjective Global Assessment [PG-SGA] score) and patient outcomes (QOL FACT-G, Symptom Distress Scale, and ECOG performance status) in weight-losing cancer patients undergoing chemotherapy who have or have not received medical nutrition therapy (MNT). (Part 2)

Secondary

  • To describe the percentage of lean body mass, weight, and QOL scores at time of presentation for cancer treatment. (Part 1)
  • To describe the percentage of lean body mass, weight, and QOL scores at subsequent time points (3, 6, 12, 18, 24, 30, and 36 months) regardless of intervention. (Part 1)
  • To determine percentage of lean body mass, weight, PG-SGA score, and QOL scores at time of initial presentation for cancer treatment in patients presenting to a comprehensive cancer center. (Part 2)
  • Measure longitudinal changes in percentage of lean body mass, weight, PG-SGA score, and QOL scores in cancer patients who have or have not received MNT. (Part 2)

OUTLINE: This is a two-part study.

  • Part 1: Patients undergo observation. Patients may receive Medical Nutritional Therapy (MNT) or standard care. Patients' health history and socio-demographic parameters, weight, height, and body mass index (BMI), Patient Generated Subjective Global Assessment (PG-SGA), bioelectrical impedance analysis (BIA), quality of life, and survival data are measured at baseline and at 3, 6, 12, 24, and 36 months.
  • Part 2: Patients are stratified according to tumor type (pancreatic vs lung vs prostate). Patients are then randomized to 1 of 2 arms.

    • Arm I (MNT session): Patients undergo one MNT session at baseline, weeks 2-3, and weeks 6-9. Patients also meet with a registered dietitian (RD) in month 6.
    • Arm II (standard care): Patients undergo standard care. Patients requiring nutritional intervention are followed by the RD as requested by the patient or healthcare team are taken off study. Patients undergo standard nutrition counseling including a 24-hour dietary recall to measure compliance at each treatment visit. Patients found to be non-compliant are counseled to promote compliance.

In both arms, patients' weight, quality of life, and body composition are measured using the Functional Assessment of Cancer Therapy-General (FACT-G), the Symptom Distress Scale (SDS), ECOG performance status, BIA, and PG-SGA score.

All patients receive the National Cancer Institute's booklet "Eating Hints for Cancer Patients: Before, During & After Treatment."

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Supportive Care
  • Lung Cancer
  • Malnutrition
  • Pancreatic Cancer
  • Prostate Cancer
  • Weight Changes
  • Behavioral: compliance monitoring
  • Dietary Supplement: dietary intervention
  • Dietary Supplement: nutritional intervention
  • Drug: chemotherapy
  • Other: counseling intervention
  • Other: medical chart review
  • Other: questionnaire administration
  • Other: study of socioeconomic and demographic variables
  • Procedure: management of therapy complications
  • Procedure: observation
  • Procedure: quality-of-life assessment
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
230
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, CINJ-000605, CINJ-IRB-0220060217
Yes
Maureen Huhmann, UMDNJ/CINJ
University of Medicine and Dentistry New Jersey
National Cancer Institute (NCI)
Principal Investigator: Maureen Huhmann, MD Cancer Institute of New Jersey
University of Medicine and Dentistry New Jersey
December 2009

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