Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer

OBJECTIVES:

• Compare the change in lean body mass of patients treated with Juven® vs a non-Juven® supplement.
• Compare the change in fatigue and quality of life of patients treated with these supplements.
• Compare the results of plethysmography, bioimpedance, and skinfold measurement in patients treated with these supplements.
• Compare the weight change in patients treated with these supplements.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to primary disease site (lung vs others), concurrent chemotherapy (yes vs no), evidence of metastases (yes vs no), and degree of weight loss (2-5% vs 6-10%). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral Juven® supplement twice daily for 8 weeks.
• Arm II: Patients receive oral non-Juven® supplement twice daily for 8 weeks. All patients undergo lean body mass measurement (to include multiple body composition and weight change) and fatigue and quality of life assessments at baseline and then at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 468 patients (234 per treatment arm) will be accrued for this study within 16 months.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor or lymphoma with no leukemic aspect

• Stage III or IV or any other stage associated with current metastatic disease at presentation
• No primary or metastatic brain tumors
• Weight loss of at least 2% but no more than 10% within the past 3 months
• No ascites

PATIENT CHARACTERISTICS:

Age

• 17 and over

Performance status

• Zubrod 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• No hypercalcemia

Cardiovascular

• No persistent moderate or severe peripheral edema
• No uncontrolled congestive heart failure

Gastrointestinal

• No enteric fistula
• No concurrent intestinal obstruction

• Prior intestinal obstruction allowed

Other

• Not pregnant or nursing
• Negative pregnancy test
• No uncontrolled infections
• No other serious medical illness
• No metabolic disorder

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Concurrent chemotherapy allowed

Endocrine therapy

• No dexamethasone as an appetite stimulant
• Intermittent dexamethasone during concurrent chemotherapy allowed

Radiotherapy

• Concurrent radiotherapy allowed

Surgery

• At least 1 week since prior minor surgery
• At least 3 weeks since prior major surgery

Other

• At least 30 days since prior total parenteral nutrition
• No concurrent parenteral feedings
• No concurrent known appetite stimulants (e.g., megestrol or dronabinol)
• No concurrent omega 3 fatty acids or their congeners (e.g., ProSure™)
• No concurrent amino acid supplements
• Concurrent use of other dietary supplements (e.g., Ensure® or Boost) is allowed
• Concurrent enteral feedings via PEG or nasogastric tube are allowed