NCT05336266Active, not recruitingEarly Phase 1
IIT2021-16-Hendifar-KetoROCX: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Andrew Hendifar, MD1 site in 1 country28 target enrollmentStarted: July 1, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
Study Overview
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 pancreatic cancer patients.
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 study-provided FitBit along with weight using a study-provided smart scale.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Ketorolac (open label)
Experimental
Pancreatic patients receiving Ketorolac four times a day for up to five days
Intervention: Ketorolac Tromethamine (Drug)
Outcomes
Primary Outcomes
Feasibility determined by the number of patients that take the prescribed dose of ketorolac (4 times daily) for 5 consecutive days.
Time Frame: 6 days
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
- Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit(14 days)
- Mean change in peak heart rate from baseline(14 days)
- Mean change in sleep duration from baseline(14 days)
- Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline(6 days)
- Mean change in calories consumed from baseline through the End-of-Treatment visit(6 days)
- To describe the adverse events associated with ketorolac when administered.(14 days)
- Mean change in daily activity (step taken) from baseline(14 days)
- Mean change in average heart rate from baseline(14 days)
- Mean change in sleep disturbances from baseline(14 days)
- Mean change in daily active minutes from baseline(14 days)
- Mean change in weight from baseline through the End-of-Study visit(14 days)
- Mean change in body fat from baseline through the End-of-Study visit(14 days)
- Evaluate change in physical function from baseline through the End-of Study visit(14 days)
Investigators
Andrew Hendifar, MD
Assistant Professor, Medicine
Cedars-Sinai Medical Center
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Prophylactic Ketorolac Post Epiretinal Membrane SurgeryMacular EdemaNCT00974753Queen's University18
Completed
Phase 3
Effect of Ketorolac in incidence of post operative shiveringIRCT2016080229162N1Vice Chancellor for research of Ardabil University of Medical Sciences60
Completed
Phase 2
Evaluating the effect of injection of ketorolac or dexamethasone on pain and swelling following removal of third molarimpacted teeth.Impacted teethIRCT20180910040981N1Kerman University of Medical Sciences60
Completed
Phase 2
Comparison of clinical effectiveness of ketorolac and Triamcinolone injection in patients with moderate to severe carpal tunnel syndromeCarpal tunnel syndromeIRCT20190326043118N1Vice chancellor for research, Tabriz University of Medical Sciences45
Completed
Phase 2
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic RetinopathyProliferative Diabetic RetinopathyMacular EdemaNCT00907114Hospital Juarez de Mexico44