- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003077
Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
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.
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Delaware
-
Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
-
-
New York
-
Manhasset, New York, United States, 11030
- North Shore University Hospital
-
New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
survival
Time Frame: up to 4 months
|
up to 4 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: C. Patrick Burns, MD, Holden Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Other Study ID Numbers
- CALGB-9473
- U10CA031946 (U.S. NIH Grant/Contract)
- CLB-9473
- NCI-P97-0097
- CDR0000065766 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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