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

Primary Purpose

Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
omega-3 fatty acid
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Leukemia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Christiana Care Health Services
  • Holden Comprehensive Cancer Center at The University of Iowa
  • North Shore University Hospital
  • New York Presbyterian Hospital - Cornell Campus
  • CCOP - Southeast Cancer Control Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omega-3 fatty acid

Arm Description

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.

Outcomes

Primary Outcome Measures

survival

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003077
Brief Title
Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Official Title
Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 1995 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
November 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omega-3 fatty acid
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acid
Primary Outcome Measure Information:
Title
survival
Time Frame
up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Patrick Burns, MD
Organizational Affiliation
Holden Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Christiana Care Health Services
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15241836
Citation
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.
Results Reference
result

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

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