Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The data collected through this pilot study will allow us to increase our understanding of cancer cachexia and the effect of Eicosapentaenoic Acid (EPA) on cancer cachexia. Our long-term goal is to improve nutritional treatment and reduce illness in the cancer patient population.
People who have cancer can get what is called cancer cachexia (CC). The symptoms of CC include getting full quickly when eating (early satiety), loss of appetite, weakness resulting in weight loss and loss of lean body mass. Even a weight loss of 5% in cancer patients reflects poor health, hospitalization, and a higher rate of illness. Research shows that the elderly are at higher risk for deficiency of vitamins and trace minerals. Other pre-existing chronic diseases and drug therapies in this population may increase the needs of certain nutrients. Recent studies have also shown that advanced malnutrition is much more difficult to treat in the elderly than in younger adults, and the consequences of failure to treat it delays recovery and can decrease function and quality of life. At this time, the ways to treat CC include giving medications to increase appetite and giving nutritional supplements that are high in calories and protein.
Recent studies have shown that certain types of fats that are present in fish, walnuts and other foods that we eat called Eicosapentaenoic acid (EPA) may help with weight gain, especially gain in muscle and improve quality of life in patients with pancreatic cancer. However, EPA has never been studied in prevention of cancer cachexia in cancer patients showing early signs of weight loss. Based on these early, small studies, it is clear that we need to study if and how EPA can prevent loss of muscle and weight in cancer patients and prevent this from becoming worse.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eicosapentaenoic Acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eicosapentaenoic Acid | Drug | Participants will receive Lovaza at a dose of 4 g for 6 weeks. Participants will be examined at six weeks for change in protein status as indicated by change in morphological (Height, weight, body mass index, body composition, lean body mass, body fat %), and biochemical (serum prealbumin) markers of protein status and immunological cytokines (Il-6, TNF- α) markers implicated in cancer cachexia. At baseline, 3 and 6 weeks, participants will undergo interviews and laboratory analysis for determining compliance and treatment-related toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Albumin | Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers. | 6 weeks per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%. | There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nagi Kumar, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martin Memorial | Stuart | Florida | 34997 | United States | ||
| H. Lee Moffitt Cancer Center & Research Institute |
Not provided
Eligible participants will include cancer patients with Men and Women >25 years of age (inclusive), with a confirmed diagnosis of cancer, unintentional weight loss of >5% of body weight, using uniform established diagnostic criteria and be admitted to the study within 3 month of diagnosis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Eicosapentaenoic Acid (Lovaza) | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Eicosapentaenoic Acid (Lovaza) | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Serum Albumin | Change in protein status at 6 weeks after initial diagnosis of weight loss of >5% body weight as indicated by morphological, biochemical and immunological intermediate biomarkers. | Posted | Median | Full Range | g/dL | 6 weeks per patient |
|
|
6 weeks per participant
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eicosapentaenoic Acid (Lovaza) | Participants to receive Lovaza at a dose of 4 g for 6 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CNS | Vascular disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
This was a Pilot Supportive Care Intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nagi Kumar, Ph.D., via Moffitt Cancer Center | H. Lee Moffitt Cancer Center and Research Institute | 813-745-6885 | nagi.kumar@moffitt.org |
Not provided
| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| C405603 | Omacor |
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 6 weeks per patient |
| Tampa |
| Florida |
| 33612 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Number of Participants With Proteasome Activity That Was Inhibited in the Range of 6%-29%. | There is no expected range for "normal" activity since there is not currently a clinical indication for these molecular markers. Comparison of ranges can be made between groups (such as those that received treatment and not). This was an exploration of potential in the pilot study and further research is indicated to better understand the metabolic abnormalities observed in cancer cachexia as well as potential benefits of using agents such as EPA. | Participants with available pre and post-treatment serum samples. | Posted | Number | Participants | 6 weeks per patient |
|
|
|
| 4 |
| 36 |
| 26 |
| 36 |
| Dehydration | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Febrile Neutropenia | General disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Glucose serum-high | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Hypotension | Cardiac disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Mucositis/stomach - Oral cavity | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Pain - Chest/Thorax | General disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Pain - abdomen | General disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Potassium serum-low | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Vomitting | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Anorexia | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Bruising in absence of Grade 3 or 4 thrombocytopenia | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - possibly related |
|
| Constipation | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 2 - unlikely to be related |
|
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 2 - possibly related |
|
| Diarrhea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Distension/bloating, abdominal | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Dizziness | General disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Edema: limb | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 2 - unrelated |
|
| Fatigue | General disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Glucose, serum-high | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
|
| Hair loss | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Hemoglobin | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Hemorrhage: nose | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Insomnia | General disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| International Normalized Ratio of prothrombin time (INR) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 2 - unlikely to be related |
|
| Mucositis/stomatitis | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Nail changes | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Nasal cavity/paranasal sinus reaction | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1 - possibly related |
|
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
|
| Nausea | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Neuropathy: sensory | Musculoskeletal and connective tissue disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 3 - unrelated |
|
| Opthalmoplegia/diplopia (double vision) | Eye disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Pain - Chest/thorax NOS | General disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Pain - Extremity-limb | General disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Pain - back | General disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Pain - head/headache | General disorders | CTC V3 | Systematic Assessment | Grade 2 - unlikely to be related |
|
| Pain - lymph node | General disorders | CTC V3 | Systematic Assessment | Grade 1 - unrelated |
|
| Pain - neck | General disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Pain - sinus | General disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Pain - stomach | General disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Partial Thromboplastin Time (PTT) | Blood and lymphatic system disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
|
| Rash | Skin and subcutaneous tissue disorders | CTC V3 | Systematic Assessment | Grade 1 - unrelated |
|
| Rigors/chills | General disorders | CTC V3 | Systematic Assessment | Grade 2 - unrelated |
|
| Sodium, serum-low | Metabolism and nutrition disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unrelated |
|
| Sweating | General disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Taste alteration | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Urine color change | Renal and urinary disorders | CTC V3 | Systematic Assessment | Grade 1 - unlikely to be related |
|
| Voice changes | Respiratory, thoracic and mediastinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Vomiting | Gastrointestinal disorders | CTC V3 | Systematic Assessment | Grade 1-3 - unlikely to be related |
|
| Weight loss | General disorders | CTC V3 | Systematic Assessment | Grade 2 - unrelated |
|
Not provided
Not provided
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |