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Trial record 8 of 78 for:    Not yet recruiting Studies | amphetamine OR cocaine OR heroin OR marijuana OR ketamine

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

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ClinicalTrials.gov Identifier: NCT03362073
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Kwonoh Park, Pusan National University Yangsan Hospital

Brief Summary:
To establish the role of ketamine in hospitalized terminally ill cancer patients with refractory cancer pain, using continuous intravenous infusion of ketamine

Condition or disease Intervention/treatment Phase
Ketamine Refractory Cancer Pain Drug: Ketamine Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, Single institution, Open-label, Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients With Refractory Cancer Pain
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
continuous intravenous infusion of ketamine
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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. 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

  3. 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)

  4. 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)

  5. Safety [ Time Frame: From date of enrollment until 5 days or drop-out, assess up to 2 years ]
    Rate of Ketamine-related adverse events

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 160 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362073


Contacts
Contact: Kwonoh Park, MD, PhD +82-10-3378-3529 parkkoh@daum.net
Contact: Mikyung Kang tesoon@hanmail.net

Locations
Korea, Republic of
Pusan National University Yangsan Hospital Not yet recruiting
Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
Contact: Kwonoh Park, MD, PhD    82+-10-3378-3529    parkkoh@daum.net   
Sub-Investigator: So Yeon Oh         
Sub-Investigator: Sang-Bo Oh         
Sub-Investigator: Eun-Ju Park         
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
Principal Investigator: Kwonoh Park, MD, PhD Pusan National University Yangsan Hospital

Publications of Results:
Responsible Party: Kwonoh Park, Professor, clinical research, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03362073     History of Changes
Other Study ID Numbers: CIVIK
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kwonoh Park, Pusan National University Yangsan Hospital:
Ketamine
Refractory cancer pain
Terminally ill cancer patients
Palliative care

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action