Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Closed 17 and over NCI RTOG-0122 RTOG-0122, RTOG 0122, NCT00053053

Objectives

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

Entry 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

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

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

Expected Enrollment

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

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.

Berk L, James J, Schwartz A, et al.: A randomized, double-blind, placebo-controlled trial of a beta-hydroxyl beta-methyl butyrate, glutamine, and arginine mixture for the treatment of cancer cachexia (RTOG 0122). Support Care Cancer : , 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Lawrence Berk, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 614-448-2118

Registry Information
Official Title		A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
Trial Start Date		2002-12-06
Registered in ClinicalTrials.gov		NCT00053053
Date Submitted to PDQ		2002-11-14
Information Last Verified		2006-09-07