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

• ClinicalTrials.gov Identifier: NCT00003077
• Recruitment Status: Completed
• First Posted: October 22, 2003
• Last Update Posted: July 13, 2016
• Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Alliance for Clinical Trials in Oncology

Tracking Information

• First Submitted Date: November 1, 1999
• First Posted Date: October 22, 2003
• Last Update Posted Date: July 13, 2016
• Study Start Date: October 1995
• Actual Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 6, 2015): survival [ Time Frame: up to 4 months ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm

• Intervention: Dietary Supplement: omega-3 fatty acid

Study Arms

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.

Intervention: Dietary Supplement: omega-3 fatty acid

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 15, 2007): 63
• Original Enrollment: Not Provided
• Actual Study Completion Date: November 2004
• Actual Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alliance for Clinical Trials in Oncology
• Study Sponsor: Alliance for Clinical Trials in Oncology
• Collaborators: National Cancer Institute (NCI)

Investigators

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

• PRS Account: Alliance for Clinical Trials in Oncology
• Verification Date: July 2016