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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究場所
-
-
Delaware
-
Wilmington、Delaware、アメリカ、19899
- CCOP - Christiana Care Health Services
-
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Iowa
-
Iowa City、Iowa、アメリカ、52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
-
-
New York
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Manhasset、New York、アメリカ、11030
- North Shore University Hospital
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New York、New York、アメリカ、10021
- New York Presbyterian Hospital - Cornell Campus
-
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North Carolina
-
Winston-Salem、North Carolina、アメリカ、27104-4241
- CCOP - Southeast Cancer Control Consortium
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
survival
時間枠:up to 4 months
|
up to 4 months
|
協力者と研究者
捜査官
- スタディチェア:C. Patrick Burns, MD、Holden Comprehensive Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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