Clinical trial · Interventional
Comparison of Megestrol and/or Omega-3 Fatty Acid-Enriched Nutritional Supplement in Treating Patients With Cancer-Related Weight Loss and Lack of Appetite
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Megestrol Acetate (Megace) Versus an N-3 Fatty Acid (EPA) Enriched Nutritional Supplement Versus Both for the Treatment of Cancer Cachexia and Anorexia
- 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: Megestrol and /or an omega-3 fatty acid-enriched nutritional supplement may improve cancer-related weight loss and lack of appetite. It is not yet known whether megestrol alone, an omega-3 fatty acid-enriched nutritional supplement alone, or a combination of both is most effective in treating cancer-related weight loss and loss of appetite. PURPOSE: Randomized phase III trial to compare the effectiveness of megestrol with or without an omega-3 fatty acid-enriched nutritional supplement to that of the omega-3 fatty acid-enriched nutritional supplement alone in treating patients who have cancer-related weight loss and lack of appetite.
Conditions
Conditions (2)
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 | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| eicosapentaenoic acid | Dietary Supplement | — | UNRESOLVED |
| megestrol acetate | Drug | Megestrol | ALIAS |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- megestrol + placebo
- description
- Patients receive oral megestrol once daily and oral placebo twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.
- interventionNames
- Drug: megestrol acetate
- Other: placebo
- type
- ACTIVE_COMPARATOR
- label
- eicosapentaenoic acid + placebo
- description
- Patients receive oral placebo once daily and an eicosapentaenoic acid (EPA)-enriched nutritional supplement twice daily. Treatment continues in the absence of unacceptable toxicity and as long as the patient and physician feel it is beneficial. Quality of life is assessed at baseline, weekly for 1 month, and then monthly thereafter during study treatment. Patients are followed every 6 months for 5 years.
- interventionNames
- Dietary Supplement: eicosapentaenoic acid
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically proven cancer other than brain, breast, ovarian, endometrial, or prostate cancer * Compelling clinical evidence of cancer is allowed when tissue sample is unobtainable * Considered incurable with available therapies * At least 5 pounds weight loss within the past 2 months (excluding perioperative weight loss) and/or have estimated caloric intake of less than 20 cal/kg daily * Weight loss must be perceived as a problem by the patient * Potential weight gain must be considered beneficial by the attending physician * No history of primary brain cancer or brain metastases * No clinical evidence of ascites PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Cardiovascular: * No poorly controlled congestive heart failure * No poorly controlled hypertension * No history of thromboembolic disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * Alert and mentally competent * Able to reliably take oral medication * No known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (more than 5 episodes per week) * No diabetes requiring insulin * Diabetes requiring an oral hypoglycemic agent or diet control allowed PRIOR CONCURRENT THERAPY: Chemotherapy: * Concurrent chemotherapy allowed Endocrine therapy: * At least 1 month since prior adrenal steroids, androgens, progestational agents, or appetite stimulants (e.g., dronabinol) * No concurrent adrenal steroids, androgens, other progestational agents, or appetite stimulants (e.g., dronabinol) * Inhalant, topical, or optical steroids allowed * Short-term dexamethasone as an anti-emetic during chemotherapy allowed Radiotherapy: * Concurrent radiotherapy allowed Other: * No tube feedings or parenteral nutrition
References
Publications (1)
- RESULTJatoi A, Rowland K, Loprinzi CL, Sloan JA, Dakhil SR, MacDonald N, Gagnon B, Novotny PJ, Mailliard JA, Bushey TI, Nair S, Christensen B; North Central Cancer Treatment Group. An eicosapentaenoic acid supplement versus megestrol acetate versus both for patients with cancer-associated wasting: a North Central Cancer Treatment Group and National Cancer Institute of Canada collaborative effort. J Clin Oncol. 2004 Jun 15;22(12):2469-76. doi: 10.1200/JCO.2004.06.024. PMID 15197210