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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00053053
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : December 8, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cachexia Lymphoma Lymphoproliferative Disorder Unspecified Adult Solid Tumor, Protocol Specific Dietary Supplement: Juven Dietary Supplement: Non-Juven Supplement Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement
Study Start Date : December 2002
Actual Primary Completion Date : March 2005
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Juven supplement
Juven nutritional supplement given twice a day for 8 weeks
 Dietary Supplement: Juven
Active Comparator: Non-Juven supplement
Non-Juven nutritional supplement given twice a day for 8 weeks
 Dietary Supplement: Non-Juven Supplement


Outcome Measures
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Primary Outcome Measures :
  1. Lean body mass [ Time Frame: Study entry to 8 weeks ]

Secondary Outcome Measures :
  1. Fatigue [ Time Frame: Study entry to 8 weeks ]
  2. Quality of Life [ Time Frame: Study entry to 8 weeks ]
  3. Body weight [ Time Frame: Study entry to 8 weeks ]
  4. Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement [ Time Frame: Study entry to 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   17 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053053


Locations
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Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Lawrence B. Berk, MD, PhD CCOP - Columbus
More Information
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Publications of Results:

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Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00053053    
Other Study ID Numbers: RTOG-0122
CDR0000269100
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: October 2013
Keywords provided by Radiation Therapy Oncology Group:
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoproliferative Disorders
Wasting Syndrome
Cachexia
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders