What side effects are associated with this type of intervention?

Common treatments for cancer pain management, particularly those involving interventions on the spinal cord like cordotomy, can have side effects such as infection, bleeding, and neurological complications including weakness or sensory changes. Long-term opioid use, often employed for pain management, can lead to dependence and other opioid-related side effects. Non-pharmacologic options like acupuncture and hypnotherapy generally have fewer side effects but may vary in their effectiveness.

What prior FDA approvals exist?

FDA-approved treatments for managing pain in advanced cancer cases include various pharmacological and procedural interventions. Opioids like morphine and fentanyl are commonly used for severe cancer pain. Additionally, procedures such as nerve blocks and epidural injections are employed to manage pain by targeting specific nerve pathways. While cordotomy itself is a specialized procedure for interrupting pain pathways in the spinal cord, other neurosurgical techniques like spinal cord stimulation and intrathecal drug delivery systems are also approved for managing intractable cancer pain.

What other types of research exist?

Promising alternatives to cordotomy for cancer patients include: <ol> <li>Non-inhaled medical cannabis or cannabinoids for advanced cancer with neuropathic pain unresponsive to opioids.</li> <li></li> </ol> Botulinum toxin injections for refractory focal pain. 3. Ketamine for treatment-refractory neuropathic pain. 4. Spinal cord stimulation for chronic pain management. 5. Biofeedback-assisted relaxation and mindfulness-based interventions for pain reduction.

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Procedure

Cordotomy for Cancer Pain Management

N/A

Recruiting

Led By Eduardo Bruera

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)

Has undergone 3 palliative care evaluations

Must not have

Uncorrectable coagulopathy

Large intracranial mass

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial studies how well cordotomy works in reducing severe pain in patients with advanced cancer. Cordotomy involves using a needle to make a small cut in the spinal cord, which helps block pain signals from reaching the brain. The goal is to see if this method can effectively reduce pain when other treatments don't work. Cordotomy has been used since 1912 and has evolved from a more invasive open surgical procedure to a less invasive percutaneous radiofrequency procedure.

Who is the study for?

This trial is for advanced cancer patients with pain intensity of 4 or higher on a scale of 0-10, specifically below the shoulder level. Participants must have had three palliative care evaluations and be able to consent. Those who can't complete forms, have less than a month to live, issues with blood clotting, sedation risks, brain tumors or morphine allergies cannot join.

What is being tested?

The study tests if cordotomy—a needle procedure on the spinal cord guided by CT scans—can reduce severe cancer-related pain better than standard treatments like morphine. Patients will also answer questionnaires about their pain levels.

What are the potential side effects?

Cordotomy may cause discomfort at the injection site, potential nerve damage leading to weakness or numbness, and risks associated with sedation. Morphine's side effects include drowsiness, constipation, nausea and potential dependency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have cancer-related pain in one side of my body below the shoulder.

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I have had three evaluations for symptom management and support.

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My pain level is 4 or higher on a scale of 0 to 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood clotting disorder that cannot be corrected.

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I have a large brain tumor.

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I cannot have medicines that make me sleep through an IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in pain intensity

Secondary study objectives

Brief Pain Inventory pain interference items

Other ESAS symptoms

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group I (cordotomy)Experimental Treatment2 Interventions

Patients undergo a cordotomy over 1-2 hours.

Group II: Group II (morphine, fake cordotomy)Placebo Group3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cordotomy

2015

N/A

~20

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cordotomy is a surgical procedure that interrupts pain pathways in the spinal cord, providing relief for cancer patients with severe, refractory pain. This is particularly important for those with advanced cancer, as it can significantly improve their quality of life. Other treatments, such as radiation therapy, work by shrinking tumors that cause pain through pressure on nerves or bones. Pharmacologic approaches, including opioids and adjuvant analgesics, modulate pain perception at different points in the nervous system. Understanding these mechanisms allows for personalized pain management strategies, enhancing patient comfort and daily functioning.

Surgical cordotomy helps psychosocial suffering.Minimally Invasive Cordotomy for Refractory Cancer Pain: A Randomized Controlled Trial.