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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

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE October 8, 2019
Last Update Posted Date December 17, 2019
Actual Study Start Date  ICMJE September 16, 2019
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2019)		 Reduction in pain intensity [ Time Frame: Up to 6 months ]
Will be measured by the Edmonton Symptom Assessment Scale (ESAS).
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2019)		 Reduction in pain intensity: Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: Up to 6 months ]
ESAS consists of 10 symptom items to measure severity of participants symptoms. Grading severity of symptoms from "no" 0 to "worst symptom" 10.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2019)
  • Brief Pain Inventory pain interference items [ Time Frame: Up to 6 months ]
    Will provide initial estimates of the magnitude of the effect of cordotomy.
  • Other ESAS symptoms [ Time Frame: Up to 6 months ]
    Will provide initial estimates of the magnitude of the effect of cordotomy.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2019)
  • Brief Pain Inventory (BPI) [ Time Frame: Up to 6 months ]
    to assess the severity of pain and impact of pain on daily functions. Consists of 9 items rated on a 0-10 scale with higher scores indicating higher pain.
  • Patient Global Impression Of Changes (PGIC) [ Time Frame: Up to 6 months ]
    7 point Likert-type response scale ranging from "very much worse " to "very much improved" cancer pain related symptoms or overall condition.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cordotomy in Reducing Pain in Patients With Advanced Cancer
Official Title  ICMJE Percutaneous Cordotomy for Pain Palliation in Advanced Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Advanced Malignant Neoplasm
Intervention  ICMJE
  • Procedure: Cordotomy
    Undergo cordotomy
  • Drug: Morphine
    Given via injection
  • Other: Questionnaire Administration
    Ancillary studies
  • Procedure: Sham Intervention
    Undergo fake cordotomy
Study Arms  ICMJE
  • Experimental: Group I (cordotomy)
    Patients undergo a cordotomy over 1-2 hours.
    Interventions:
    • Procedure: Cordotomy
    • Other: Questionnaire Administration
  • Sham Comparator: Group II (morphine, fake cordotomy)
    Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
    Interventions:
    • Drug: Morphine
    • Other: Questionnaire Administration
    • Procedure: Sham Intervention
Publications * Not Provided

*   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: October 4, 2019)		 42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2024
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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: Ashwin Viswanatha 713-792-6085 aviswanathan@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04119037
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
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 Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE M.D. Anderson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Ashwin Viswanathan M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date December 2019

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