Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 5
- 主要终点
- survival
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •AST less than 3 times upper limit of normal (ULN)
- •Alkaline phosphatase less than 3 times ULN
- •Bilirubin less than 1.5 times ULN
- •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
- •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
- •Greater than 3 weeks since major surgery
- •Greater than 1 week since minor surgery
- •No concurrent diuretics
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: omega-3 fatty acid (Dietary Supplement)
结局指标
主要结局
survival
时间窗: up to 4 months
次要结局
未报告次要终点