Continuous IntraVenous Infusion of Ketamine in Terminally Ill Cancer Patients

NCT03362073 | Unknown Phase 2

• 1 other identifier: CIVIK
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ketamine; Refractory Cancer Pain

Keywords

Ketamine; Refractory cancer pain; Terminally ill cancer patients; Palliative care

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  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

  From date of enrollment until 5 days or drop-out, assess up to 2 years

Secondary Outcomes (7)

• Change of pain intensity

  From date of enrollment until 5 days or drop-out, assess up to 2 years

• Rescue analgesics for breakthrough pain

  From date of enrollment until 5 days or drop-out, assess up to 2 years

• Patient's satisfaction about Ketamine by a newly developed question in this study

  at the 5th days or drop-out, assess up to 2 years

• Guardian's satisfaction about Ketamine by a newly developed question in this study

  at the 5th days or drop-out, assess up to 2 years

• Rate of Ketamine-related adverse events

  From date of enrollment until 5 days or drop-out, assess up to 2 years

Study Arms (1)

Ketamine

EXPERIMENTAL

continuous intravenous infusion of ketamine

Drug: Ketamine

Interventions

Ketamine DRUG

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)

Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• Hospitalized patients with intravascular access during at least 5 days
• Age 18 or older
• 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

You may not qualify if:

• Patients who were treated with ketamine for pain control within 6 months
• Patients who have been treated with radiotherapy within 4 weeks or plan to intervention for pain control during study period
• Cancer pain cannot be excluded the Opioid induced hyperalgesia
• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

Related Publications (8)

• van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.

  PMID: 17355955 RESULT

• Zech DFJ, Grond S, Lynch J, Hertel D, Lehmann KA. Validation of World Health Organization Guidelines for cancer pain relief: a 10-year prospective study. Pain. 1995 Oct;63(1):65-76. doi: 10.1016/0304-3959(95)00017-M.

  PMID: 8577492 RESULT

• Hanks GW, Justins DM. Cancer pain: management. Lancet. 1992 Apr 25;339(8800):1031-6. doi: 10.1016/0140-6736(92)90546-f. No abstract available.

  PMID: 1349061 RESULT

• Hardy J, Quinn S, Fazekas B, Plummer J, Eckermann S, Agar M, Spruyt O, Rowett D, Currow DC. Randomized, double-blind, placebo-controlled study to assess the efficacy and toxicity of subcutaneous ketamine in the management of cancer pain. J Clin Oncol. 2012 Oct 10;30(29):3611-7. doi: 10.1200/JCO.2012.42.1081. Epub 2012 Sep 10.

  PMID: 22965960 RESULT

• Jackson K, Ashby M, Martin P, Pisasale M, Brumley D, Hayes B. "Burst" ketamine for refractory cancer pain: an open-label audit of 39 patients. J Pain Symptom Manage. 2001 Oct;22(4):834-42. doi: 10.1016/s0885-3924(01)00340-2.

  PMID: 11576800 RESULT

• Mercadante S, Arcuri E, Tirelli W, Casuccio A. Analgesic effect of intravenous ketamine in cancer patients on morphine therapy: a randomized, controlled, double-blind, crossover, double-dose study. J Pain Symptom Manage. 2000 Oct;20(4):246-52. doi: 10.1016/s0885-3924(00)00194-9.

  PMID: 11027905 RESULT

• Bell RF, Eccleston C, Kalso EA. Ketamine as an adjuvant to opioids for cancer pain. Cochrane Database Syst Rev. 2017 Jun 28;6(6):CD003351. doi: 10.1002/14651858.CD003351.pub3.

  PMID: 28657160 RESULT

• Park K, Kim JJ, Oh SB, Oh SY, Hong YJ, Kim SJ, Park EJ, Choi N, Shin SH, Kim S, Ko H. A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine as Adjuvant to Opioids in Terminally Ill Cancer Patients With Refractory Cancer Pain (CIVIK Trial). Am J Hosp Palliat Care. 2025 Mar;42(3):244-252. doi: 10.1177/10499091241252977. Epub 2024 May 16.

  PMID: 38752431 DERIVED

MeSH Terms

Conditions

Cancer Pain

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Kwonoh Park, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kwonoh Park, MD, PhD

CONTACT

+82-10-3378-3529; parkkoh@daum.net

Mikyung Kang

CONTACT

tesoon@hanmail.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, clinical research

Model Details: Prospective, Single institution, Open-label, Phase 2

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 5, 2017
• Study Start: June 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)