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

NCT ID: NCT00003077

Last Updated: 2016-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-10-31
• Study Completion Date: 2004-11-30

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.

Detailed Description

OBJECTIVES:

• Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer patients with cachexia.
• Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients (phase I completed 12/1999).
• Determine whether omega-3 fatty acids will result in an antitumor response.

OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by the extent of weight loss (2-5 percent or greater than 5 percent in the past month).

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. The maximum tolerated dose (MTD) is defined as the highest dose level at which no greater than one-third of the patients treated, including escalated patients from a lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).

Conditions

Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Omega-3 fatty acid

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.

Group Type: EXPERIMENTAL

omega-3 fatty acid

Intervention Type: DIETARY_SUPPLEMENT

Interventions

omega-3 fatty acid

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

C. Patrick Burns, MD

Role: STUDY_CHAIR

Holden Comprehensive Cancer Center

Locations

CCOP - Christiana Care Health Services

Wilmington, Delaware, United States

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, United States

North Shore University Hospital

Manhasset, New York, United States

New York Presbyterian Hospital - Cornell Campus

New York, New York, United States

CCOP - Southeast Cancer Control Consortium

Winston-Salem, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 15241836 (View on PubMed)

Other Identifiers

U10CA031946

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CLB-9473

Identifier Type: -

Identifier Source: secondary_id

NCI-P97-0097

Identifier Type: -

Identifier Source: secondary_id

CDR0000065766

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-9473

Identifier Type: -

Identifier Source: org_study_id