Status:
ACTIVE_NOT_RECRUITING
A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Lead Sponsor:
Andrew Hendifar, MD
Collaborating Sponsors:
Yinuoke Ltd.
Conditions:
Pancreas Cancer
Pancreatic Ductal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 pancreati...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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:
- Creatinine OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal OR ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN.
- Patient must have access to WiFi for the Smart Scale.
Exclusion
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
- Pregnancy, breastfeeding, or of childbearing potential and not willing to use adequate methods of contraception during the study.
- Has any known allergies or hypersensitivity to the study drug or allergic reactions to surgical steel or elastomer/rubber.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Concurrent use of any other NSAIDs while on study.
- Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding.
- Have suspected or confirmed cerebrovascular bleeding, tendency to bleed or bruise easily, incomplete hemostasis (how you body stops bleeding), and at high risk of bleeding.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05336266
Start Date
July 1 2022
End Date
December 5 2026
Last Update
January 6 2026
Active Locations (1)
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1
Cedars- Sinai Medical Center
Los Angeles, California, United States, 90048