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

Phase 3
17 Years
Not Enrolling
Cachexia, Lymphoma, Lymphoproliferative Disorder, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


- Compare the change in lean body mass of patients treated with Juven® vs a non-Juven®

- Compare the change in fatigue and quality of life of patients treated with these

- 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.

Inclusion Criteria


- Histologically or cytologically confirmed solid tumor or lymphoma with no leukemic

- Stage III or IV or any other stage associated with current metastatic disease at

- No primary or metastatic brain tumors

- Weight loss of at least 2% but no more than 10% within the past 3 months

- No ascites



- 17 and over

Performance status

- Zubrod 0-2

Life expectancy

- At least 3 months


- Not specified


- Not specified


- No hypercalcemia


- No persistent moderate or severe peripheral edema

- No uncontrolled congestive heart failure


- No enteric fistula

- No concurrent intestinal obstruction

- Prior intestinal obstruction allowed


- Not pregnant or nursing

- Negative pregnancy test

- No uncontrolled infections

- No other serious medical illness

- No metabolic disorder


Biologic therapy

- Not specified


- Concurrent chemotherapy allowed

Endocrine therapy

- No dexamethasone as an appetite stimulant

- Intermittent dexamethasone during concurrent chemotherapy allowed


- Concurrent radiotherapy allowed


- At least 1 week since prior minor surgery

- At least 3 weeks since prior major surgery


- 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

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Lawrence B. Berk, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

CCOP - Columbus


United States: Federal Government

Study ID:




Start Date:

December 2002

Completion Date:

Related Keywords:

  • Cachexia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Cachexia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic



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