Expired Study
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New Brunswick, New Jersey 08903


Purpose:

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.


Study summary:

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."


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


NCT ID:

NCT00769652


Primary Contact:

Principal Investigator
Maureen Huhmann, MD
Cancer Institute of New Jersey


Backup Contact:

N/A


Location Contact:

New Brunswick, New Jersey 08903
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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