Clinical trial · Interventional
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia
NCT00046904CI-TRIAL-00004776completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cachexia | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| etanercept | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Comparison of weight gain and rate of weight change
Secondary outcomes (4)
- measure
- Differences in appetite
- measure
- Overall survival
- measure
- Incidence of treatment-related toxicity
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * 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) Gastrointestinal * 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 Other * 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 PRIOR CONCURRENT THERAPY: Biologic therapy * More than 1 month since prior infliximab * No concurrent live vaccination Chemotherapy * 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 Radiotherapy * Concurrent radiotherapy allowed Surgery * Not specified Other * 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)
References
Publications (2)
- RESULTJatoi A, Dakhil SR, Nguyen PL, Sloan JA, Kugler JW, Rowland KM Jr, Soori GS, Wender DB, Fitch TR, Novotny PJ, Loprinzi CL. A placebo-controlled double blind trial of etanercept for the cancer anorexia/weight loss syndrome: results from N00C1 from the North Central Cancer Treatment Group. Cancer. 2007 Sep 15;110(6):1396-403. doi: 10.1002/cncr.22944. PMID 17674351
- RESULTJatoi 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.