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

Phase 1

Completed

• Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Leukemia; Lymphoma
• Interventions: Dietary Supplement: omega-3 fatty acid

• Registration Number: NCT00003077
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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).

Study Timeline

• Study Start: 1995-10
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-10-21
• Study First Posted: 2003-10-22
• Primary Completion: 2004-07
• Study Completion: 2004-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omega-3 fatty acid	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.

Primary Outcome Measures

Name	Time	Method
survival	up to 4 months

Trial Locations

Locations (5)

CCOP - Christiana Care Health Services; 🇺🇸 Wilmington, Delaware, United States

Holden Comprehensive Cancer Center at The University of Iowa; 🇺🇸 Iowa City, Iowa, United States

North Shore University Hospital; 🇺🇸 Manhasset, New York, United States

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Winston-Salem, North Carolina, United States