Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm
Intervention: omega-3 fatty acids (Drug); anticachectic therapy (Procedure); nutritional support (Procedure)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Cancer and Leukemia Group B Official(s) and/or principal investigator(s):
C. Patrick Burns, MD, Study Chair, Affiliation: Holden Comprehensive Cancer Center
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.
Clinical Details
Official title: Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
Study design: Supportive Care, Randomized, Active Control
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).
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.
PROJECTED ACCRUAL: A total of 57-63 patients will be enrolled in the Phase I and II study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States
Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa 52242-1009, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York 10021, United States
North Shore University Hospital, Manhasset, New York 11030, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina 27104-4241, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1995
Last updated: December 15, 2007
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