Clinical trial · Interventional
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
NCT00053053CI-TRIAL-00025075completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cachexia | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoproliferative Disorder | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Juven | Dietary Supplement | — | UNRESOLVED |
| Non-Juven Supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Juven supplement
- description
- Juven nutritional supplement given twice a day for 8 weeks
- interventionNames
- Dietary Supplement: Juven
- type
- ACTIVE_COMPARATOR
- label
- Non-Juven supplement
- description
- Non-Juven nutritional supplement given twice a day for 8 weeks
- interventionNames
- Dietary Supplement: Non-Juven Supplement
Primary outcomes (1)
- measure
- Lean body mass
- timeFrame
- Study entry to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBerk L, James J, Schwartz A, Hug E, Mahadevan A, Samuels M, Kachnic L; RTOG. 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 Oct;16(10):1179-88. doi: 10.1007/s00520-008-0403-7. Epub 2008 Feb 22. PMID 18293016