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Nonsteroidal Anti-inflammatory Drug

Ketorolac for Cachexia in Pancreatic Cancer (KetoROCX Trial)

Phase < 1
Recruiting
Research Sponsored by Andrew Hendifar, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status >50%
Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights

KetoROCX Trial Summary

This trial will see if taking ketorolac helps pancreatic cancer patients with weight and quality of life.

Who is the study for?
This trial is for adults with advanced pancreatic cancer and cachexia, which means they've lost a lot of weight due to illness. They need good kidney function, internet access for a Smart Scale, and an ECOG performance status ≤2 or Karnofsky >50%. Pregnant women or those at risk of bleeding can't join.Check my eligibility
What is being tested?
The study tests if ketorolac, an anti-inflammatory drug, is safe and effective in stabilizing or increasing the weight and improving quality of life in patients with advanced pancreatic cancer who are experiencing significant weight loss.See study design
What are the potential side effects?
Ketorolac may cause side effects like stomach ulcers, gastrointestinal bleeding, kidney problems, allergic reactions, and increased risk of bleeding. It's important to monitor these potential issues throughout the trial.

KetoROCX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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I have advanced pancreatic cancer that has not responded to treatment and am referred to Cedars-Sinai.
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My kidney function, measured by creatinine levels or filtration rate, is within the required range.

KetoROCX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
Secondary outcome measures
Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline
Evaluate change in physical function from baseline through the End-of Study visit
Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit
+10 more

KetoROCX Trial Design

1Treatment groups
Experimental Treatment
Group I: Ketorolac (open label)Experimental Treatment1 Intervention
Pancreatic patients receiving Ketorolac four times a day for up to five days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac Tromethamine
2007
Completed Phase 4
~1450

Find a Location

Who is running the clinical trial?

Yinuoke Ltd.UNKNOWN
Andrew Hendifar, MDLead Sponsor
5 Previous Clinical Trials
103 Total Patients Enrolled

Media Library

Ketorolac Tromethamine (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05336266 — Phase < 1
Pancreatic Cancer Research Study Groups: Ketorolac (open label)
Pancreatic Cancer Clinical Trial 2023: Ketorolac Tromethamine Highlights & Side Effects. Trial Name: NCT05336266 — Phase < 1
Ketorolac Tromethamine (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336266 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently engaged in this trial?

"Affirmative. According to clinicaltrials.gov, the recruitment process for this medical trial is still going on and began on July 1st 2022, with a recent update being posted on July 15th of that same year. The team needs 20 individuals at one location to partake in their research."

Answered by AI

Are there still available positions for those interested in contributing to this research?

"Currently, the clinical trial is open to recruitment as declared on clinicaltrials.gov; its initial posting was July 1st 2022 and it was last updated two weeks later on July 15th."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Andrew Hendifar, MD 2022. "A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336266.
~5 spots leftby Dec 2024
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