Cordotomy in Reducing Pain in Patients With Advanced Cancer

• ClinicalTrials.gov Identifier: NCT04119037
• Recruitment Status: Recruiting
• First Posted: October 8, 2019
• Last Update Posted: December 17, 2019
• Sponsor: M.D. Anderson Cancer Center
• 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: September 11, 2019
• First Posted Date: October 8, 2019
• Last Update Posted Date: December 17, 2019
• Actual Study Start Date: September 16, 2019
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Cordotomy in Reducing Pain in Patients With Advanced Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Advanced Malignant Neoplasm

Intervention

• Procedure: Cordotomy
  Undergo cordotomy
• Drug: Morphine
  Given via injection
• Other: Questionnaire Administration
  Ancillary studies
• Procedure: Sham Intervention
  Undergo fake cordotomy

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 4, 2019): 42
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2024
• Estimated Primary Completion Date: September 30, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: 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 )
• 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: Not Provided
• Responsible Party: M.D. Anderson Cancer Center
• Study Sponsor: M.D. Anderson Cancer Center

Collaborators

• National Cancer Institute (NCI)
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Ashwin Viswanathan; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: December 2019