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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is studying how well cordotomy works in reducing pain for patients with advanced cancer. Cordotomy is a procedure where a needle is used to target the spinal cord, guided by CT scans. The study is being done to see if cordotomy can help reduce pain for patients with cancer who can't manage their pain.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in pain intensity

Secondary outcome measures

Brief Pain Inventory pain interference items

Other ESAS symptoms

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 / 3Eligibility 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.