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2022-07-01
2025-02-19
2026-12-05
28
NCT05336266
Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
INTERVENTIONAL
A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-03-11 | N/A | 2025-03-25 |
2022-04-15 | N/A | 2025-03-27 |
2022-04-20 | N/A | 2025-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Ketorolac (open label) Pancreatic patients receiving Ketorolac four times a day for up to five days | DRUG: Ketorolac Tromethamine
|
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | -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 | * 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. | 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. | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
