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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053053
  Purpose

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 Intervention Phase
Cachexia
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Juven
Phase III

MedlinePlus related topics:   Cancer    Dietary Supplements    Hodgkin's Disease    Lymphoma    Weight Control   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Active Control
Official Title:   A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 2002

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.

  Eligibility
Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053053

Show 250 study locations  Show 250 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Lawrence B. Berk, MD, PhD     CCOP - Columbus    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000269100, RTOG-0122
First Received:   January 27, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00053053
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Hodgkin's disease
Hodgkin lymphoma, adult
Cutaneous T-cell lymphoma
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Cachexia
Lymphoma, B-Cell, Marginal Zone
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Body Weight
Burkitt's lymphoma
Signs and Symptoms
Lymphoma, T-Cell
Lymphoma, Large-Cell, Immunoblastic
Weight Loss
Lymphoma, Large-Cell, Anaplastic
Body Weight Changes
Hodgkin Disease
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoblastic lymphoma
Emaciation
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
B-cell lymphomas

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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