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Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01207206
First received: September 21, 2010
Last updated: October 31, 2011
Last verified: September 2010
History of Changes
  Purpose

In the current research the investigators would like to examine the effect of a well acquainted drug, Ketamine, which is used by anesthesiologists to induce sleep in operations. Usually the ketamine is given into the vein and not orally. The investigators want to give it orally to cancer patients that sufffer from severe pain to find out whether it can prove their quality of life, lower their pain and reduce the amount of opioids they receive.


Condition Intervention
Cancer
Pain
Tolerance
 Drug: oral ketamine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Ketamine as an Adjuvant to Opioids for Pain Treatment in Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • The capability of oral ketamine treatment to reduce pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The study is a prospective randomized, placebo-controlled double -blind study involving. Subjects Fifty patients with unbalanced (VAS>6) chronic cancer-related pain despite opioid treatment.


Secondary Outcome Measures:
  • evaluation of side effects related to ketamine in cancer pain patients [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    The study is a prospective randomized, placebo-controlled double -blind study involving. Subjects Fifty patients with unbalanced (VAS>6) chronic cancer-related pain despite opioid treatment.


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: oral ketamine

    The group will be divided into two pain matched groups of 25 each. One group will receive Ketamine (K group) and the other placebo (P). Both the researchers and the patients will not know to which group they belong. Four days prior to the beginning of the research the patients will document, using an ad-hoc diary, in predetermined hours, four times a day the level (VAS) of pain, sedation and vomiting scores, and other side effects. Pain will be assessed using a Visual Analog Scale (VAS) (0-10).

    The documentation will continue throughout the research period. The Ketamine or plaecebo will also be taken in a predetermined hours to avoid an effect of diurnal disruption on pain perception

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patient suffering from severe cancer pain (VAS>6 at rest or on movement) despite the opioid treatment.

    2. Opiate tolerance suspected on the basis of rapid escalation in opiate dose 3. Severe opiate side effects

Exclusion Criteria:

  • 1. Recent psychiatric hospitalization, suicide attempt, or history within the preceding month of electroconvulsive therapy 2. History of psychosis, eg, schizophrenia 3. History of recent seizures 4. Uncontrolled intracranial hypertension due to brain metastasis or hydrocephalus 5. Severe labile hypertension or poorly controlled cardiac arrhythmia 6. Chronic obstructive pulmonary disease (COPD) associated with hypercarbia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207206

Contacts
Contact: Silviu Brill, MD 972-3-6974477 silviub@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky Medical Center, Pain Medicine Unit Recruiting
Tel Aviv, Israel
Contact: silviu Brill, M.D     972-3-6974477     silviub@tasmc.health.gov.il    
Principal Investigator: Silviu Brill, M.D            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Silviu Brill MD, Tel aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01207206     History of Changes
Other Study ID Numbers: TASMC-10-SB-392-CTIL
Study First Received: September 21, 2010
Last Updated: October 31, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Patient suffering from severe cancer pain despite the opioid treatment
Opiate tolerance suspected on the basis of rapid escalation in opiate dose
Severe opiate side effects

Additional relevant MeSH terms:
Ketamine
Analgesics, Opioid
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013