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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 3

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Lymphoproliferative Disorder; Cachexia; Lymphoma

Treatments: Dietary Supplement: Juven; Dietary Supplement: Non-Juven Supplement

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00053053

RTOG-0122

CDR0000269100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 472 patients

Sex: All

Ages: 17 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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472 participants in 2 patient groups

Juven supplement

Experimental group

Description:

Juven nutritional supplement given twice a day for 8 weeks

Treatment:

Dietary Supplement: Juven

Non-Juven supplement

Active Comparator group

Description:

Non-Juven nutritional supplement given twice a day for 8 weeks

Treatment:

Dietary Supplement: Non-Juven Supplement