Lung Cancer, Malnutrition, Pancreatic Cancer, Prostate Cancer, Weight Changes
Conditions
Keywords
malnutrition, non-small cell lung cancer, small cell lung cancer, stage III prostate cancer, stage IV prostate cancer, pancreatic cancer, weight changes
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.
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.
Interventions
BEHAVIORALMedical 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.
BEHAVIORALStandard Care
Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment.
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Eight subjects were enrolled from October 2006 through May 2007 at Rutgers Cancer Institute of New Jersey, a comprehensive cancer center.
Pre-assignment details
1 subject was consented but did not get randomized.
Participants by arm
| Arm | Count |
|---|---|
| Medical Nutrition Therapy Medical nutrition therapy
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. | 6 |
| Standard Care Standard care
Standard Care : Standard nutritional care includes the National Cancer Institute's booklet Eating Hints for cancer patients: before, during & after treatment. | 1 |
| Total | 7 |
Baseline characteristics
| Characteristic | Standard Care | Medical Nutrition Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 4 Participants | 5 Participants |
| Age, Continuous | 60 years | 61 years STANDARD_DEVIATION 4.9 | 60.9 years STANDARD_DEVIATION 4.5 |
| Region of Enrollment United States | 1 participants | 6 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 6 | 1 / 1 |
| other Total, other adverse events | 0 / 6 | 0 / 1 |
| serious Total, serious adverse events | 0 / 6 | 0 / 1 |
Outcome results
Primary
Change in Fat Free Mass (FFM)
Time frame: 3 years
Population: The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.
Primary
Change in Patient Generated Subjective Global Assessment (PG-SGA) Score at Time of Initial Presentation and Throughout Study
Time frame: 3 years
Population: The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.
Primary
Change in Weight
Time frame: 3 years
Population: The study was closed early due to slow accrual and insufficient data was collected to analyze this outcome measure.