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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
Trial treatment of ketorolac 10mg orally four times a day for 5 consecutive days
Cedars- Sinai Medical Center
Los Angeles, California, United States
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.
Time frame: 6 days
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.
Time frame: 14 days
Mean change in weight from baseline through the End-of-Study visit
-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.
Time frame: 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.
Time frame: 14 days
Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit
* Mean change in reported pain, sleep disturbance, and mood (anxiety/depression) using the NIH PROMIS-29 profile v2.1. * The PROMIS-29 profile v2.1 questionnaire consists of 29 questions that ask the subject to rate : 1) how easy it is to perform routine tasks, 2) how mood impacts daily living, 3) quality of sleep, 4) feelings of fatigue, and 5) pain and how it impacts daily living. Each question is answered on a scale of 1-5, where higher scores indicate the most impact or severity. The questionnaire responses at baseline, end of treatment and end of study will be compared.
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Time frame: 14 days
Evaluate change in physical function from baseline through the End-of Study visit
* Mean change in reported physical function using the National Institute of Health (NIH) PROMIS Health Organization and PROMIS Cooperative Group questionnaire v2.0. * The NIH PROMIS Scale consists of 165 questions that ask the subject to rate their physical function. Each question is answered on a scale of 1-5 where higher scores indicate the lowest level of difficulty. The questionnaire responses at baseline, end of treatment and end of study will be compared.
Time frame: 14 days
Mean change in daily activity (step taken) from baseline
As measured by continuous daily wearable activity monitor
Time frame: 14 days
Mean change in average heart rate from baseline
As measured by continuous daily wearable activity monitor
Time frame: 14 days
Mean change in peak heart rate from baseline
As measured by continuous daily wearable activity monitor
Time frame: 14 days
Mean change in sleep duration from baseline
As measured by continuous daily wearable activity monitor
Time frame: 14 days
Mean change in sleep disturbances from baseline
As measured by continuous daily wearable activity monitor
Time frame: 14 days
Mean change in daily active minutes from baseline
As measured by continuous daily wearable activity monitor
Time frame: 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
Time frame: 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.
Time frame: 6 days