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| Name | Class |
|---|---|
| Yinuoke Ltd. | UNKNOWN |
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The purpose of this study is to see if taking ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is reasonable, safe and can stabilize or increase weight along with quality of life in pancreatic cancer patients.
The main things that will happen in this study are: patients will be administered ketorolac for 5 days, blood draws, completion of questionnaires, monitoring physical activity and sleep by wearing a study-provided FitBit along with weight using a study-provided smart scale.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac (open label) | Experimental | Pancreatic patients receiving Ketorolac four times a day for up to five days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine | Drug | Trial treatment of ketorolac 10mg orally four times a day for 5 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days. | Defined as 75% or more of patients taking the study medication as prescribed for 5 days in a 6-day period: compliance diary. | 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the adverse events associated with ketorolac when administered. | -Safety is defined as stable or decreased number of adverse events (AEs) compared to published trials for the same chemotherapy. | 14 days |
| Mean change in weight from baseline through the End-of-Study visit |
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Inclusion Criteria:
Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC).
Cachexia defined as ≥5% weight loss in the presence of chronic illness, within any 6-month period prior to screening or as documented by the medical physician based on standard diagnosis of cachexia.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status >50%.
Patient must have adequate renal function per below lab values:
Patient must have access to WiFi for the Smart Scale.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Hendifar, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars- Sinai Medical Center | Los Angeles | California | 90048 | United States |
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-Body weight stability is defined as weight change < 0.1kg/baseline Body Mass Index-unit from Baseline (start of 1 week lead-in prior to Day 1) to Day 6. Weight will be measured using the Aria Smart Scale. Changes in weight from Day 6 to Day 14 and from Day 1 to Day 14 will also be evaluated long term. |
| 14 days |
| Mean change in body fat from baseline through the End-of-Study visit | -Body fat percentage will be measured using the Aria smart scale and compared from Baseline (start of 1 week lead-in prior to Day 1) to Day 6. Changes in body fat percentage from Day 6 to Day 14 and from Day 1 to Day 14 will also be evaluated long term. An increase in body fat percentage will be regarded as a positive outcome. | 14 days |
| Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit |
| 14 days |
| Evaluate change in physical function from baseline through the End-of Study visit |
| 14 days |
| Mean change in daily activity (step taken) from baseline | As measured by continuous daily wearable activity monitor | 14 days |
| Mean change in average heart rate from baseline | As measured by continuous daily wearable activity monitor | 14 days |
| Mean change in peak heart rate from baseline | As measured by continuous daily wearable activity monitor | 14 days |
| Mean change in sleep duration from baseline | As measured by continuous daily wearable activity monitor | 14 days |
| Mean change in sleep disturbances from baseline | As measured by continuous daily wearable activity monitor | 14 days |
| Mean change in daily active minutes from baseline | As measured by continuous daily wearable activity monitor | 14 days |
| Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline | CA-19 and CRP lab results from baseline will be compared to results from Day 6 | 6 days |
| Mean change in calories consumed from baseline through the End-of-Treatment visit | As measured by Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool. The ASA is a system to collect 24-hour food recalls and provide complete nutrient analysis of the foods and beverages consumed during the collection timeframe. The tool is used in this study to calculate total calories consumed. | 6 days |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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