Cachexia, Lymphoma, Lymphoproliferative Disorder, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
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
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.
Interventions
DIETARY_SUPPLEMENTJuven
DIETARY_SUPPLEMENTNon-Juven Supplement
Sponsors
National Cancer Institute (NCI)
Radiation Therapy Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
17 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lean body mass | Study entry to 8 weeks |
Secondary
| Measure | 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 |
Countries
Canada, United States
Outcome results
None listed