Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss

NCT00003077 | Completed Phase 1

• 5 other identifiers: CALGB-9473U10CA031946CLB-9473NCI-P97-0097CDR0000065766
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may be an effective treatment for patients with advanced cancer who are unable to maintain their body weight. PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss.

Conditions

Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

• survival

  up to 4 months

Study Arms (1)

Omega-3 fatty acid

EXPERIMENTAL

Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and lunch for 4 months or until weight loss is observed. Dose is escalated in cohorts of two patients, although dose escalation is allowed in individual patients. Patients are evaluated for cachexia response every 2 weeks, and tumor response every 4 weeks for a maximum of 4 months. If no response of cachexia or tumor after a 2 month period, patients will be discontinued from study. Patients will be followed for survival post-treatment.

Dietary Supplement: omega-3 fatty acid

Interventions

omega-3 fatty acid DIETARY_SUPPLEMENT

Omega-3 fatty acid

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically proven advanced cancer not amenable to curative therapy (solid tumors and hematologic malignancies eligible except primary and metastatic brain tumors) * Cachexia (weight loss at least 2 percent within a one month period) PATIENT CHARACTERISTICS: Age: * 18 and over Performance Status: * CALBG 0-2 Life Expectancy: * At least 2 months Hematopoietic: * Granulocytes greater than 1,000/mm3 * Platelet count greater than 75,000/mm3 * Hemoglobin greater than 8 mg/dL Hepatic: * AST less than 3 times upper limit of normal (ULN) * Alkaline phosphatase less than 3 times ULN * Bilirubin less than 1.5 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Cardiovascular: * No congestive heart failure requiring diuretics within less than 6 months * No uncontrolled or severe cardiovascular disease within less than 6 months * No myocardial infarction within less than 6 months Other: * Not pregnant nor contemplating pregnancy during study * Negative pregnancy test * No uncontrolled hypercalcemia * No metabolic disorders (hyperthyroidism) * No poorly controlled diabetes * No peripheral edema or ascites requiring diuretics * No enteric fistulas, with tracheobronchial fistulas or with aspiration * No esophageal or bowel obstruction that would preclude eating * Free T4 within normal range * No serious medical illness * No psychosis * No uncontrolled bacterial, viral, or fungal infections * No active uncontrolled duodenal ulcers * Above laboratory values required unless bone marrow, liver, kidney, or splenic involvement by tumor is documented PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior and concurrent chemotherapy allowed Endocrine therapy: * No concurrent steroids such as dronabinol or megestrol acetate (except for adrenal failure) Radiotherapy: * No prior or concurrent radiotherapy to abdomen or pelvis Surgery: * Greater than 3 weeks since major surgery * Greater than 1 week since minor surgery Other: * No concurrent diuretics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

CCOP - Christiana Care Health Services

Wilmington, Delaware, 19899, United States

Location

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, 27104-4241, United States

Location

Related Publications (1)

• Burns CP, Halabi S, Clamon G, Kaplan E, Hohl RJ, Atkins JN, Schwartz MA, Wagner BA, Paskett E. Phase II study of high-dose fish oil capsules for patients with cancer-related cachexia. Cancer. 2004 Jul 15;101(2):370-8. doi: 10.1002/cncr.20362.

  PMID: 15241836 RESULT

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• C. Patrick Burns, MD

  Holden Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: October 22, 2003
• Study Start: October 1, 1995
• Primary Completion: July 1, 2004
• Study Completion: November 1, 2004
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (5)