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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
-
-
Delaware
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Wilmington, Delaware, 미국, 19899
- CCOP - Christiana Care Health Services
-
-
Iowa
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Iowa City, Iowa, 미국, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
-
-
New York
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Manhasset, New York, 미국, 11030
- North Shore University Hospital
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New York, New York, 미국, 10021
- New York Presbyterian Hospital - Cornell Campus
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North Carolina
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Winston-Salem, North Carolina, 미국, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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-
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자격 기준
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연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
survival
기간: up to 4 months
|
up to 4 months
|
공동 작업자 및 조사자
수사관
- 연구 의자: C. Patrick Burns, MD, Holden Comprehensive Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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