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Cordotomy in Reducing Pain in Patients With Advanced Cancer

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: NCT04119037
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. This study is being done to learn if a cordotomy reduces pain in patients with unmanageable cancer pain.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Procedure: Cordotomy Drug: Morphine Other: Questionnaire Administration Procedure: Sham Intervention Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Assess the efficacy of cordotomy for patients with unilateral advanced cancer pain.

SECONDARY OBJECTIVES:

I. Define the patient experience of cordotomy for cancer pain refractory to palliative care.

II. Determine whether magnetic resonance imaging (MRI) can be used as a noninvasive biomarker for a successful cordotomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo a cordotomy over 1-2 hours.

GROUP II: Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.

After completion of study, patients are followed up at 2 weeks and once every month for up to 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Percutaneous Cordotomy for Pain Palliation in Advanced Cancer
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Arm Intervention/treatment
Experimental: Group I (cordotomy)
Patients undergo a cordotomy over 1-2 hours.
Procedure: Cordotomy
Undergo cordotomy

Other: Questionnaire Administration
Ancillary studies

Sham Comparator: Group II (morphine, fake cordotomy)
Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
Drug: Morphine
Given via injection

Other: Questionnaire Administration
Ancillary studies

Procedure: Sham Intervention
Undergo fake cordotomy




Primary Outcome Measures :
  1. Reduction in pain intensity [ Time Frame: Up to 6 months ]
    Will be measured by the Edmonton Symptom Assessment Scale (ESAS).


Secondary Outcome Measures :
  1. Brief Pain Inventory pain interference items [ Time Frame: Up to 6 months ]
    Will provide initial estimates of the magnitude of the effect of cordotomy.

  2. Other ESAS symptoms [ Time Frame: Up to 6 months ]
    Will provide initial estimates of the magnitude of the effect of cordotomy.



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:

  • Ability to provide informed consent
  • Has undergone 3 palliative care evaluations
  • Pain intensity >= 4 on a 0-10 numerical scale
  • Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)

Exclusion Criteria:

  • Uncorrectable coagulopathy
  • Large intracranial mass
  • Inability to complete assessment forms
  • Life expectancy < 1 month
  • Contraindication to intravenous sedation
  • Morphine allergy

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): NCT04119037


Contacts
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Contact: Ashwin Viswanatha 713-792-6085 aviswanathan@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ashwin Viswanathan    713-792-6085      
Principal Investigator: Ashwin Viswanathan         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Ashwin Viswanathan M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04119037    
Other Study ID Numbers: 2019-0264
NCI-2019-03708 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-0264 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
R01NR018481 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents