Clinical trial · Interventional
A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
IIT2021-16-Hendifar-KetoROCX: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
NCT05336266CI-TRIAL-00100243KetoROCXactive not recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketorolac Tromethamine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ketorolac (open label)
- description
- Pancreatic patients receiving Ketorolac four times a day for up to five days
- interventionNames
- Drug: Ketorolac Tromethamine
Primary outcomes (1)
- measure
- Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
- timeFrame
- 6 days
- description
- Defined as 75% or more of patients taking the study medication as prescribed for 5 days in a 6-day period: compliance diary.
Secondary outcomes (13)
- measure
- To describe the adverse events associated with ketorolac when administered.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of advanced and refractory pancreatic ductal adenocarcinoma (PDAC) referred to Cedars-Sinai Medical Center (CSMC). 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky performance status \>50%. 4. 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. 5. Patient must have access to WiFi for the Smart Scale. Exclusion Criteria: 1. 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. 2. Pregnancy, breastfeeding, or of childbearing potential and not willing to use adequate methods of contraception during the study. 3. Has any known allergies or hypersensitivity to the study drug or allergic reactions to surgical steel or elastomer/rubber. 4. 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. 5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 6. Concurrent use of any other NSAIDs while on study. 7. Active peptic ulcer disease, recent gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding. 8. 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.
References
Publications (0)
Data not yet available
No reference posted for this study.