Medical Nutrition Therapy or Standard Care in Treating Patients With Lung Cancer, Pancreatic Cancer, or Stage III or Stage IV Prostate Cancer
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.
Behavioral: compliance monitoring
Dietary Supplement: dietary intervention
Dietary Supplement: nutritional intervention
Other: counseling intervention
Other: medical chart review
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: management of therapy complications
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||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|
- 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 ]
|Study Start Date:||October 2006|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- 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)
- 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."
|United States, New Jersey|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Maureen Huhmann, MD||Cancer Institute of New Jersey|