Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00053053
First received: January 27, 2003
Last updated: October 8, 2013
Last verified: October 2013

January 27, 2003
October 8, 2013
December 2002
October 2008   (final data collection date for primary outcome measure)
Lean body mass [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00053053 on ClinicalTrials.gov Archive Site
  • Fatigue [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
  • Correlation between change in lean body mass and body plethysmography, bioimpedance and skin-fold measurement [ Time Frame: Study entry to 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Comparison of Nutritional Supplements in Preventing Weight Loss in Patients With Cancer
A Double-Blind Study Of Nutritional Intervention For The Treatment Of Cancer Cachexia Using Juven® Nutritional Supplement

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Cachexia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Dietary Supplement: Juven
  • Dietary Supplement: Non-Juven Supplement
  • Experimental: Juven supplement
    Juven nutritional supplement given twice a day for 8 weeks
    Intervention: Dietary Supplement: Juven
  • Active Comparator: Non-Juven supplement
    Non-Juven nutritional supplement given twice a day for 8 weeks
    Intervention: Dietary Supplement: Non-Juven Supplement
Berk L, James J, Schwartz A, Hug E, Mahadevan A, Samuels M, Kachnic L. A randomized, double-blind, placebo-controlled trial of a beta-hydroxyl beta-methyl butyrate, glutamine, and arginine mixture for the treatment of cancer cachexia (RTOG 0122). Support Care Cancer. 2008 Feb 22; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
472
February 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00053053
RTOG-0122, CDR0000269100
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Study Chair: Lawrence B. Berk, MD, PhD CCOP - Columbus
Radiation Therapy Oncology Group
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP