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Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced 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. Identifier: NCT00046904
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 5, 2011
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Brief Summary:

RATIONALE: Etanercept is a substance that is being studied as a treatment for cachexia (weight loss) and anorexia (lack of appetite) in patients who have cancer. It is not yet known whether etanercept is effective in improving cancer-related cachexia and anorexia.

PURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer.

Condition or disease Intervention/treatment Phase
Anorexia Cachexia Unspecified Adult Solid Tumor, Protocol Specific Biological: etanercept Phase 3

Detailed Description:


  • Compare etanercept vs placebo in the treatment of cancer-related cachexia and anorexia, in terms of weight measurement and rate of weight change, in patients with advanced malignancies.
  • Determine the effect of this drug on nausea and vomiting in these patients.
  • Assess the functional status and appetite of patients treated with this drug.
  • Assess the quality of life of patients treated with this drug.
  • Determine the toxic effects of this drug in these patients.
  • Determine whether this drug prolongs survival of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to primary malignant disease (lung vs gastrointestinal vs other), severity of weight loss (less than 4.6 kg vs at least 4.6 kg), planned concurrent chemotherapy (yes vs no), age (less than 50 vs 50 and over), gender, planned use of megestrol or other progestational agent (yes vs no), and GBU Prognostic Index (good vs bad vs unsure). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive etanercept subcutaneously (SC) twice weekly.
  • Arm II: Patients receive placebo SC twice weekly. Treatment in both arms continues for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weekly for 1 month, and then monthly during treatment.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 274 patients (137 per treatment arm) will be accrued for this study within 19 months.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Supportive Care
Official Title: Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia
Study Start Date : May 2003
Actual Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Etanercept

Primary Outcome Measures :
  1. Comparison of weight gain and rate of weight change

Secondary Outcome Measures :
  1. Differences in appetite
  2. Overall survival
  3. Incidence of treatment-related toxicity
  4. Comparison of quality of life (QOL) as assessed by the QOL UNISCALE and the Functional Assessment of Cancer Therapy-Anorexia/cachexia (FACT-An) scale at baseline, weekly for one month, and then monthly during study treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed malignancy except brain cancer

    • If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be brain cancer
  • Disease considered incurable with available therapies
  • No clinical evidence of ascites
  • Weight loss of at least 5 pounds (2.3 kg) within the past 2 months (excluding perioperative weight loss) and/or estimated caloric intake of less than 20 cal/kg daily
  • Weight gain determined by physician to be beneficial
  • Patient perceives weight loss as a problem



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months


  • Not specified


  • Not specified


  • Not specified


  • No poorly controlled congestive heart failure
  • No poorly controlled hypertension
  • No pacemaker, implanted defibrillator, stents, or metal suture material in the heart or great vessels (for patients participating in the BIA translational portion of the study)


  • No known mechanical obstruction of the alimentary tract
  • No malabsorption
  • No intractable vomiting (more than 5 episodes/week)
  • Not concurrently receiving tube feedings or parenteral nutrition


  • Able to reliably administer subcutaneous medication twice weekly
  • Alert and mentally competent
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • More than 1 month since prior infliximab
  • No concurrent live vaccination


  • Concurrent chemotherapy allowed

Endocrine therapy

  • At least 1 month since prior adrenal steroids
  • No concurrent adrenal steroids (inhalant, topical, or optical steroids allowed)

    • Concurrent short-term dexamethasone for chemotherapy-induced emesis is allowed


  • Concurrent radiotherapy allowed


  • Not specified


  • More than 1 month since prior etanercept
  • No concurrent evaluation with another device that injects an electrical current into the body (for patients participating in the bioelectrical impendance analysis [BIA] translational portion of the study)

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 identifier (NCT number): NCT00046904

Show Show 19 study locations
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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Study Chair: Aminah Jatoi, MD Mayo Clinic
Publications of Results:
Jatoi A, Dakhil SR, Kugler JW, et al.: A placebo-controlled trial of etanercept, a tumor necrosis factor (TNF) inhibitor, in patients with the cancer anorexia/weight loss syndrome. North Central Cancer Treatment Group (NCCTG) trial N00C1. [Abstract] J Clin Oncol 24 (Suppl 18): A-8534, 476s, 2006.

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Responsible Party: Aminah Jatoi, M.D., Mayo Clinic Cancer Center Identifier: NCT00046904    
Other Study ID Numbers: CDR0000257027
MC00C8 ( Other Identifier: Mayo Clinic Cancer Center )
1497-00 ( Other Identifier: Mayo Clinic IRB )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 5, 2011
Last Verified: May 2011
Keywords provided by Mayo Clinic:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Wasting Syndrome
Signs and Symptoms, Digestive
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors