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

Lymphoma Clinical Trial

Official title:

Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003077
• Other study ID #: CALGB-9473
• Secondary ID: U10CA031946CLB-9
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 1999
• Last updated: July 12, 2016
• Start date: October 1995
• Est. completion date: November 2004

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Dietary Supplement:
• omega-3 fatty acid

Locations

Country	Name	City	State
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 - Christiana Care Health Services	Wilmington	Delaware
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival		up to 4 months	No