Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss
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ClinicalTrials.gov Identifier: NCT00003077 |
Recruitment Status :
Completed
First Posted : October 22, 2003
Last Update Posted : July 13, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | November 1, 1999 | |||
First Posted Date ICMJE | October 22, 2003 | |||
Last Update Posted Date | July 13, 2016 | |||
Study Start Date ICMJE | October 1995 | |||
Actual Primary Completion Date | July 2004 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
survival [ Time Frame: up to 4 months ] | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Omega-3 Fatty Acids in Treating Patients With Advanced Cancer Who Have Significant Weight Loss | |||
Official Title ICMJE | Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia | |||
Brief Summary | 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. |
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Detailed Description | OBJECTIVES:
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). |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE |
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Intervention ICMJE | Dietary Supplement: omega-3 fatty acid | |||
Study Arms ICMJE | Experimental: 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. Intervention: Dietary Supplement: omega-3 fatty acid
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Publications * | 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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
63 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | November 2004 | |||
Actual Primary Completion Date | July 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance Status:
Life Expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 120 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00003077 | |||
Other Study ID Numbers ICMJE | CALGB-9473 U10CA031946 ( U.S. NIH Grant/Contract ) CLB-9473 NCI-P97-0097 CDR0000065766 ( Registry Identifier: NCI Physician Data Query ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Alliance for Clinical Trials in Oncology | |||
Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |