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

Radiation Therapy Oncology Group472 enrolled

Overview

RATIONALE: Nutritional supplements may help prevent loss of appetite, weight loss, and fatigue in patients with advanced cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two nutritional supplements in preventing loss of appetite, weight loss, and fatigue in patients who have stage III or stage IV solid tumors.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

472

Conditions

Cachexia Lymphoma Lymphoproliferative Disorder Unspecified Adult Solid Tumor, Protocol Specific

Interventions

JuvenDIETARY_SUPPLEMENT

Non-Juven SupplementDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 17 YearsMax age: 120 Years

Medical Language ↔ Plain English

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