NCT00053053
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
PHASE3
COMPLETED
NCT00053053
INTERVENTIONAL
A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
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.
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
Cachexia
Lymphoma
Lymphoproliferative Disorder
Unspecified Adult Solid Tumor, Protocol Specific
- SUPPORTIVE_CARE
-
- Type: DIETARY_SUPPLEMENT
- Name: Juven
- Description:
- Arm Group Labels: Juven supplement
-
- Type: DIETARY_SUPPLEMENT
- Name: Non-Juven Supplement
- Description:
- Arm Group Labels: Non-Juven supplement
- Radiation Therapy Oncology Group