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Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients (CIVIK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362073
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Kwonoh Park, MD phD, Pusan National University Yangsan Hospital

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
Overall response rate [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
complete pain response plus partial pain response
  • Complete pain response is defined as patient reported pain score using numerical rating scale (range 1-10) ≤ 3 or ≤ personalized pain goal (PPG) and receiving less than four rescue analgesic doses for 24 hours, without unacceptable toxicities
  • Partial pain response is defined as receiving less than four rescue analgesic doses per day without a patient reported pain score using numerical rating scale (range 1-10) ≤ 3 or ≤ personalized pain goal for 24 hr, without unacceptable toxicities
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Change of pain intensity [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Delineate changes of pain intensity daily, from the time baseline until 5th days after application of ketamine. Pain intensity is defined as the mean of terdiurnal checked patient reported pain score during a day.
  • Rescue analgesics for breakthrough pain [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Dose and number of rescue analgesics for breakthrough pain
  • Patient's satisfaction about Ketamine by a newly developed question in this study [ Time Frame: at the 5th days or drop-out, assess up to 2 years ]
    Satisfaction about pain control and Ketamine-related distress during application of ketamine was evaluated by questions as follows: "How do you feel satisfaction about ketamine?" (at 5th days or drop-out)
  • Guardian's satisfaction about Ketamine by a newly developed question in this study [ Time Frame: at the 5th days or drop-out, assess up to 2 years ]
    Satisfaction about pain control and Ketamine-related distress during application of ketamine was evaluated by questions as follows: "How do you feel satisfaction about ketamine?" (at 5th days or drop-out)
  • Rate of Ketamine-related adverse events [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Rate of Ketamine-related adverse events
  • Rate of early discontinuation [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Rate of discontinuation due to Ketamine related AEs
  • Overall survival [ Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years ]
    Time from application of ketamine until death or discharge/transfer
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2017)
  • Change of pain intensity [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Delineate changes of pain intensity daily, from the time baseline until 5th days after application of ketamine. Pain intensity is defined as the mean of terdiurnal checked patient reported pain score during a day.
  • Rescue analgesics for breakthrough pain [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Dose and number of rescue analgesics for breakthrough pain
  • Patient's satisfaction about Ketamine by a newly developed question in this study [ Time Frame: at the 5th days or drop-out, assess up to 2 years ]
    Satisfaction about pain control and Ketamine-related distress during application of ketamine was evaluated by questions as follows: "How do you feel satisfaction about ketamine?" (at 5th days or drop-out)
  • Guardian's satisfaction about Ketamine by a newly developed question in this study [ Time Frame: at the 5th days or drop-out, assess up to 2 years ]
    Satisfaction about pain control and Ketamine-related distress during application of ketamine was evaluated by questions as follows: "How do you feel satisfaction about ketamine?" (at 5th days or drop-out)
  • Safety [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Rate of Ketamine-related adverse events
  • Rate of early discontinuation [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Rate of discontinuation due to Ketamine related AEs
  • Overall survival [ Time Frame: From date of enrollment until death or discharge/transfer, assess up to 2 years ]
    Time from application of ketamine until death or discharge/transfer
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients
Official Title  ICMJE A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients With Refractory Cancer Pain
Brief Summary To establish the role of ketamine in hospitalized terminally ill cancer patients with refractory cancer pain, using continuous intravenous infusion of ketamine
Detailed Description
  • There are approximately 20 percent patients of refractory cancer pain, which is troubled with uncontrolled pain though treatment including opioids.
  • Ketamine has been showed the performance of Ketamine, N-methyl-D-aspartate (NMDA) receptor blocker, in refractory cancer pain based on prior studies.
  • We cannot yet confirm the role of Ketamine comparing the benefit and risk due to incompatible results of prior studies. Additionally, most of prior studies were studied in heterogenous groups, which are from beginning of palliative chemotherapy to terminal status, so role of ketamine was not assessed in homogeneous terminally ill cancer patients. And they has used mostly 'bolus intravenous infusion' or 'continuous subcutaneous infusion (CSCI)', relatively rare in continuous intravenous infusion (CIVI).
  • The bolus intravenous method is convenient but is concerned with leading to relatively severe adverse events due to poor general condition of terminally ill cancer patients, the CSCI method is not recommended because of adverse events (AEs) such as skin irritation. On the contrary, the CIVI method using gradual increasing ketamine minimizes AEs and is free of skin irritation. Most of hospitalized terminally ill cancer patients has proper IV access using intravascular devices (chemoport or PICC). So, CIVI method is suitable to hospitalized terminally ill cancer patients.
  • This study assess the efficacy and safety of 5-days CIVI gradual dose titration of Ketamine in terminally ill cancer patients with refractory cancer pain.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective, Single institution, Open-label, Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ketamine
  • Refractory Cancer Pain
Intervention  ICMJE Drug: Ketamine

Application of ketamine using continuous intravenous infusion method during 5 days

  • Ketamine 100mg/2ml + 5% Dextrose water or Normal saline 98 ml mixed fluid
  • Dose schedule: 0.05mg/kg/hr -> 0.10mg/kg/hr -> … -> 0.5mg/kg/hr (increase dose at a rate of 0.05mg/kg/hr every 8 hours)
Study Arms  ICMJE Experimental: Ketamine
continuous intravenous infusion of ketamine
Intervention: Drug: Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2017)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Among patients with histologically or cytologically confirmed malignancy, patients with expected survival time of several months or less due to a progressive disease without additional anticancer treatment.
  2. Patients with refractory cancer pain, which cases of requesting 4 or more breakthrough analgesics or increase of baseline analgesics (average pain score ≥ 4 or Personalized pain goal) in spite of 120 mg/day or more of intravenous Morphine Equivalent Daily Dose
  3. Hospitalized patients with intravascular access during at least 5 days
  4. Age 18 or older
  5. Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment

Exclusion Criteria:

  1. Patients who were treated with ketamine for pain control within 6 months
  2. Patients who have been treated with radiotherapy within 4 weeks or plan to intervention for pain control during study period
  3. Cancer pain cannot be excluded the Opioid induced hyperalgesia
  4. Concomitant severe medical, surgical, or disease or problems which were contraindicated to application of Ketamine or have possibilities of unexpected medical problems caused be the Ketamine

    • confirmed or assumed central nervous system lesion which lead to increased intracranial pressure
    • Arrhythmia (supra-ventricular tachycardia, ventricular arrhythmia (frequent premature ventricular contraction, bigeminy, Ventricular tachycardia)
    • history of hemorrhagic stroke or seizure within 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kwonoh Park, MD, PhD +82-10-3378-3529 parkkoh@daum.net
Contact: Mikyung Kang tesoon@hanmail.net
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362073
Other Study ID Numbers  ICMJE CIVIK
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kwonoh Park, MD phD, Pusan National University Yangsan Hospital
Original Responsible Party Kwonoh Park, Pusan National University Yangsan Hospital, Professor, clinical research
Current Study Sponsor  ICMJE Pusan National University Yangsan Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kwonoh Park, MD, PhD Pusan National University Yangsan Hospital
PRS Account Pusan National University Yangsan Hospital
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP