Clinical trial NCT05336266: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Official title: IIT2021-16-Hendifar-KetoROCX: A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Pancreas Cancer
Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Keywords: ketorolac
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Yinuoke Ltd.
First posted: 2022-04-20
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: To describe the adverse events associated with ketorolac when administered.
timeFrame: 14 days
measure: Mean change in weight from baseline through the End-of-Study visit
timeFrame: 14 days
measure: Mean change in body fat from baseline through the End-of-Study visit
timeFrame: 14 days
measure: Evaluate change in quality of life including pain assessment from baseline through the End-of-Study visit
timeFrame: 14 days
measure: Evaluate change in physical function from baseline through the End-of Study visit
timeFrame: 14 days
measure: Mean change in daily activity (step taken) from baseline
timeFrame: 14 days
measure: Mean change in average heart rate from baseline
timeFrame: 14 days
measure: Mean change in peak heart rate from baseline
timeFrame: 14 days
measure: Mean change in sleep duration from baseline
timeFrame: 14 days
measure: Mean change in sleep disturbances from baseline
timeFrame: 14 days
measure: Mean change in daily active minutes from baseline
timeFrame: 14 days
measure: Decrease in inflammatory biomarkers (CA-19 and CRP) from baseline
timeFrame: 6 days
measure: Mean change in calories consumed from baseline through the End-of-Treatment visit
timeFrame: 6 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars- Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Andrew Hendifar, MD
role: PRINCIPAL_INVESTIGATOR
References: