Cordotomy for Cancer Pain Management

Recruiting in Palo Alto (17 mi)

Overseen by Eduardo Bruera

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Coagulopathy, Intracranial mass, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for cancer pain management?

Research suggests that percutaneous cervical cordotomy (PCC) can provide pain relief for patients with cancer-related pain that does not respond to other treatments, although there is limited evidence on its overall effectiveness and impact on quality of life. ^{1 2 3 4 5}

Is percutaneous cervical cordotomy safe for managing cancer pain?

Percutaneous cervical cordotomy (PCC) has been studied in patients with cancer pain, and while it is a recognized procedure, there is limited data on its safety. Some studies have evaluated its use in terminally ill cancer patients, but more research is needed to fully understand its safety profile. ^{1 2 4 5 6}

How is the treatment Cordotomy different from other treatments for cancer pain management?

Cordotomy is a unique treatment for cancer pain because it involves a procedure that targets and interrupts pain pathways in the spinal cord, specifically for patients whose pain does not respond to other therapies. Unlike medications, it is a surgical intervention that provides relief for unilateral (one-sided) intractable pain. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

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

I have had three evaluations for symptom management and support.

Ability to provide informed consent

Exclusion Criteria

Inability to complete assessment forms

I have a blood clotting disorder that cannot be corrected.

I have a large brain tumor.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo a cordotomy or receive morphine and a fake cordotomy over 1-2 hours

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up at 2 weeks and once every month

Treatment Details

Interventions

• Cordotomy (Procedure)

Trial Overview 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.

Participant Groups

Group I: Group I (cordotomy) Experimental Treatment 2 Interventions

Patients undergo a cordotomy over 1-2 hours.

Group II: Group II (morphine, fake cordotomy) Placebo Group 3 Interventions

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

Cordotomy is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Percutaneous Cervical Cordotomy for:

• Unilateral cancer pain
• Mesothelioma-related pain
• Lung cancer pain
• Breast cancer pain
• Brachial plexus pain

🇺🇸 Approved in United States as Percutaneous Cervical Cordotomy for:

• Advanced cancer pain
• Unilateral cancer pain
• Refractory cancer pain

🇨🇦 Approved in Canada as Percutaneous Cervical Cordotomy for:

• Cancer pain management
• Unilateral cancer pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

National Institute of Nursing Research (NINR) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy for cancer-related pain: national data. [2021] Percutaneous cervical cordotomy (PCC) is an interventional ablative procedure in the armamentarium for cancer pain treatment, but there is limited evidence to support its use. This study aimed to assess the effectiveness and safety of PCC.

2. England pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy for cancer-related pain: prospective multimodal outcomes evaluation. [2022] Percutaneous cervical cordotomy (PCC) offers pain relief to patients with unilateral treatment-refractory cancer-related pain. There is insufficient evidence about any effects of this intervention on patients' quality of life.

3. Italy pubmed.ncbi.nlm.nih.gov

[Percutaneous cervical cordotomy in cancer pain. Preliminary experience]. [2006] Suggestions of percutaneous cervical cordotomy in treatment of advanced cancer pain, limits in treatment of terminal patients (needing pain therapy and total assistance), results and complications of the latest 64 procedures (part of 110 operations performed) are discussed.

4. United States pubmed.ncbi.nlm.nih.gov

Safety of unilateral and bilateral percutaneous cervical cordotomy in 80 terminally ill cancer patients. [2017] The safety of percutaneous cervical cordotomy (PCC) and bilateral percutaneous cervical cordotomy (BPCC) was studied in 62 and 18 patients, respectively, with intractable malignant pain. Cordotomy was indicated for pain that did not respond to any other therapy.

5. United States pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy for the management of pain from cancer: a prospective review of 45 cases. [2018] Percutaneous cervical cordotomy (PCC) is a well recognized but infrequently performed procedure for the relief of unilateral intractable pain from malignancy. There is a paucity of data regarding efficacy and safety of PCC.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy. [2019] Percutaneous cervical cordotomy provides a nonoperative opportunity to interrupt the lateral spinothalamic pathways in patients with pain who are not good operative risks for an open cordotomy. The technique is relatively simple, but requires some practice. Indications should be the same as for open cordotomy, with critical patient selection. Results are comparable to those of surgical cordotomy.