Winston-Salem, North Carolina 27104

  • Multiple Myeloma and Plasma Cell Neoplasm

Purpose:

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.


Study summary:

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).


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


Study is Available At:


Original ID:

CALGB-9473


NCT ID:

NCT00003077


Secondary ID:

U10CA031946


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Alliance for Clinical Trials in Oncology


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

63


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:October 1995
Completion Date:November 2004
Completion Type:Actual
Primary Completion Date:July 2004
Primary Completion Type:Actual
Verification Date:July 2016
Last Changed Date:July 12, 2016
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:survival
Time Frame:up to 4 months
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:omega-3 fatty acid
Arm Name:Omega-3 fatty acid

Study Arms

Study Arm Type:Experimental
Arm Name:Omega-3 fatty acid
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

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Alliance for Clinical Trials in Oncology
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:15241836

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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