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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00003077

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

109

Duration (Months)

12.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm	Dietary Supplement: omega-3 fatty acid	Phase 1/Phase 2

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 Design

Study Type:

Interventional

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 :

Oct 1, 1995

Actual Primary Completion Date :

Jul 1, 2004

Actual Study Completion Date :

Nov 1, 2004

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

survival [up to 4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
2	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa	United States	52242-1009
3	North Shore University Hospital	Manhasset	New York	United States	11030
4	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
5	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241

Sponsors and Collaborators

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

Investigators

Study Chair: C. Patrick Burns, MD, Holden Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alliance for Clinical Trials in Oncology

ClinicalTrials.gov Identifier:

NCT00003077

Other Study ID Numbers:

CALGB-9473
U10CA031946
CLB-9473
NCI-P97-0097
CDR0000065766

First Posted:

Oct 22, 2003

Last Update Posted:

Jul 13, 2016

Last Verified:

Jul 1, 2016

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Plasmacytoma

Study Results

No Results Posted as of Jul 13, 2016