Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
Condition: Cachexia; Lymphoma; Lymphoproliferative Disorder; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Lymphoma; Lymphoproliferative Disorders; Wasting Syndrome; Cachexia
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Juven; Non-Juven Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
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