27 Participants Needed

Cordotomy for Cancer Pain Management

AV
EB
Overseen ByEduardo Bruera
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12346

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.12346

Who Is on the Research Team?

EB

Eduardo Bruera

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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
See 1 more

Exclusion Criteria

Inability to complete assessment forms
I have a blood clotting disorder that cannot be corrected.
I have a large brain tumor.
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Cordotomy
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.
How Is the Trial Designed?
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.

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Published Research Related to This Trial

Percutaneous cervical cordotomy (PCC) significantly reduced average pain scores from 6 to 2 and worst pain scores from 9 to 3 in cancer patients, indicating its effectiveness in managing cancer-related pain.
The procedure was associated with a 50% reduction in strong opioid use and had a low incidence of adverse events (4%), suggesting it is a safe option for pain management in this patient population.
Percutaneous cervical cordotomy for cancer-related pain: national data.Poolman, M., Makin, M., Briggs, J., et al.[2021]
Percutaneous cervical cordotomy (PCC) significantly reduces pain in patients with unilateral cancer-related pain, with improvements sustained for at least 4 weeks after the procedure.
Despite the reduction in pain and opioid intake, PCC did not lead to significant improvements in overall quality of life as measured by the EuroQol-5 dimension (EQ-5D) scores in patients with terminal cancer.
Percutaneous cervical cordotomy for cancer-related pain: prospective multimodal outcomes evaluation.Doyle, A., Sharma, ML., Gupta, M., et al.[2022]
Percutaneous cervical cordotomy has been evaluated as a treatment for advanced cancer pain, with a focus on its effectiveness and complications in terminal patients requiring pain management.
Out of 110 procedures performed, the results and complications of the latest 64 procedures were specifically discussed, highlighting the procedure's potential benefits and limitations in this patient population.
[Percutaneous cervical cordotomy in cancer pain. Preliminary experience].Orlandini, G.[2006]

Citations

Percutaneous cervical cordotomy for cancer-related pain: national data. [2021]
Percutaneous cervical cordotomy for cancer-related pain: prospective multimodal outcomes evaluation. [2022]
[Percutaneous cervical cordotomy in cancer pain. Preliminary experience]. [2006]
Safety of unilateral and bilateral percutaneous cervical cordotomy in 80 terminally ill cancer patients. [2017]
Percutaneous cervical cordotomy for the management of pain from cancer: a prospective review of 45 cases. [2018]
Percutaneous cervical cordotomy. [2019]
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