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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003077
First received: November 1, 1999
Last updated: February 19, 2012
Last verified: February 2007

November 1, 1999
February 19, 2012
October 1995
November 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003077 on ClinicalTrials.gov Archive Site
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Not Provided
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Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia

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.

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).

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.

PROJECTED ACCRUAL: A total of 57-63 patients will be enrolled in the Phase I and II study.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Primary Purpose: Supportive Care
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
Dietary Supplement: omega-3 fatty acid
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
Not Provided
November 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003077
CDR0000065766, CLB-9473, NCI-P97-0097
Not Provided
Not Provided
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: C. Patrick Burns, MD Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP