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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

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

Intervention / Treatment
-----------------
* Dietary Supplement: Juven
* Dietary Supplement: Non-Juven Supplement


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Juven supplement<br>Juven nutritional supplement given twice a day for 8 weeks | Dietary Supplement: Juven<br> <br> |
| Active Comparator: Non-Juven supplement<br>Non-Juven nutritional supplement given twice a day for 8 weeks | Dietary Supplement: Non-Juven Supplement<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass |  | Study entry to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue |  | Study entry to 8 weeks | 
| Quality of Life |  | Study entry to 8 weeks | 
| Body weight |  | Study entry to 8 weeks | 
| Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement |  | Study entry to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific, cachexia, recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Burkitt lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, intraocular lymphoma, AIDS-related peripheral/systemic lymphoma, recurrent adult Burkitt lymphoma, anaplastic large cell lymphoma, post-transplant lymphoproliferative disorder, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma