Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
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ClinicalTrials.gov Identifier: NCT00003077 |
Recruitment Status :
Completed
First Posted : October 22, 2003
Last Update Posted : July 13, 2016
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm | Dietary Supplement: omega-3 fatty acid | Phase 1 Phase 2 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia |
Study Start Date : | October 1995 |
Actual Primary Completion Date : | July 2004 |
Actual Study Completion Date : | November 2004 |

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. |
Dietary Supplement: omega-3 fatty acid |
- survival [ Time Frame: up to 4 months ]

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003077
United States, Delaware | |
CCOP - Christiana Care Health Services | |
Wilmington, Delaware, United States, 19899 | |
United States, Iowa | |
Holden Comprehensive Cancer Center at The University of Iowa | |
Iowa City, Iowa, United States, 52242-1009 | |
United States, New York | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
New York Presbyterian Hospital - Cornell Campus | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
CCOP - Southeast Cancer Control Consortium | |
Winston-Salem, North Carolina, United States, 27104-4241 |
Study Chair: | C. Patrick Burns, MD | Holden Comprehensive Cancer Center |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00003077 |
Other Study ID Numbers: |
CALGB-9473 U10CA031946 ( U.S. NIH Grant/Contract ) CLB-9473 NCI-P97-0097 CDR0000065766 ( Registry Identifier: NCI Physician Data Query ) |
First Posted: | October 22, 2003 Key Record Dates |
Last Update Posted: | July 13, 2016 |
Last Verified: | July 2016 |
Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |