Cordotomy for Cancer Pain Management

Overseen By Eduardo Bruera

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Coagulopathy, Intracranial mass, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how effectively a procedure called cordotomy reduces pain in people with advanced cancer. A cordotomy uses a needle to target specific nerves in the spinal cord to manage pain. The trial will compare the effects of an actual cordotomy to a simulated one with morphine injections. Candidates for this trial experience cancer-related pain on one side of their body, below the shoulder, and find it difficult to manage with other treatments. As an unphased trial, this study provides a unique opportunity to explore innovative pain management options for those struggling with severe cancer-related pain.

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 prior data suggests that cordotomy is safe for cancer pain management?

Research has shown that cordotomy is generally safe for treating cancer-related pain. Cordotomy, a procedure on the spinal cord, helps relieve pain. Studies have found it effective in reducing pain for cancer patients.

Most patients handle the procedure well, and serious side effects are rare. One study found that cordotomy safely manages pain on one side of the body. Another study confirmed its safety and effectiveness with recent data.

In summary, while all medical procedures carry some risk, the safety data for cordotomy in treating cancer pain is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cordotomy for cancer pain management because it offers a targeted approach that differs from standard treatments like opioids. Unlike traditional pain relief methods, which generally involve systemic medication like morphine, cordotomy involves a surgical procedure on the spinal cord that aims to interrupt pain signals directly. This could potentially provide more effective pain relief with fewer side effects. Additionally, cordotomy's direct action on the nervous system may offer faster and more sustainable pain management for patients with severe cancer pain.

What evidence suggests that cordotomy is effective for reducing cancer pain?

Research has shown that cordotomy, a treatment in this trial, effectively reduces cancer-related pain. This procedure, known as percutaneous cervical cordotomy, targets specific pain pathways in the spinal cord to provide significant relief. For instance, 86% of patients who underwent CT-guided percutaneous cordotomy reported pain relief. This option is particularly beneficial for patients whose pain isn't well-controlled by other treatments. Overall, cordotomy is considered a safe and effective method for managing severe cancer pain. Participants in this trial may receive either the actual cordotomy or a sham procedure with morphine to compare outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

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

Exclusion Criteria

Inability to complete assessment forms

I have a blood clotting disorder that cannot be corrected.

I have a large brain tumor.

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?

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

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) is a safe and effective procedure for relieving severe unilateral cancer pain, with 32 out of 45 patients reporting complete pain relief just 2 days after the procedure.

Patients experienced significant and sustained reductions in pain scores at both 2 days and 28 days post-procedure, with no serious adverse events reported, highlighting PCC's advantages over conventional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy for the management of pain from cancer: a prospective review of 45 cases. Bain, E., Hugel, H., Sharma, M.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy for cancer-related pain: national data. Poolman, M., Makin, M., Briggs, J., et al.[2021]

Percutaneous cervical cordotomy (PCC) is effective for treating intractable malignant pain, with 87% of patients experiencing satisfactory or partial pain relief, while bilateral percutaneous cervical cordotomy (BPCC) showed lower effectiveness with only 50% achieving similar relief.

PCC has a manageable complication rate, with major permanent complications occurring in about 6.5% to 8.1% of patients, but BPCC is not recommended due to a higher incidence of complications and a higher failure rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of unilateral and bilateral percutaneous cervical cordotomy in 80 terminally ill cancer patients. Sanders, M., Zuurmond, W.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Percutaneous cervical cordotomy in cancer pain. Preliminary experience]. Orlandini, G.[2006]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy for cancer-related pain: prospective multimodal outcomes evaluation. Doyle, A., Sharma, ML., Gupta, M., et al.[2022]

Percutaneous cervical cordotomy is a minimally invasive technique that effectively interrupts pain pathways in patients who are not suitable candidates for traditional open cordotomy, providing a valuable alternative for pain management.

The outcomes of percutaneous cervical cordotomy are comparable to those of surgical cordotomy, highlighting its efficacy in selected patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous cervical cordotomy. Gildenberg, PL.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32220943/

Percutaneous cervical cordotomy for cancer-related pain PCC is an effective treatment for cancer pain; however, findings in this study suggest PCC referrals tended to be late in patients' disease trajectories.

2. spcare.bmj.com spcare.bmj.com/content/10/4/429

Percutaneous cervical cordotomy for cancer-related pain PCC is an effective treatment for cancer pain; however, findings in this study suggest PCC referrals tended to be late in patients' disease trajectories.

3. bjaed.org bjaed.org/article/S1743-1816(17)30118-X/fulltext

Role of percutaneous cervical cordotomy in cancer pain ... Percutaneous cervical cordotomy (PCC) ablates the sensory pathways of the lateral spinothalamic tract and is a safe and effective technique for unilateral pain ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798324006231

Cordotomy for pain control and opioid reduction in cancer ... Percutaneous lateral cervical cordotomy is a valuable therapeutic intervention for patients experiencing cancer pain that is unresponsive to conservative ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/papr.13307

Effectiveness of CT‐guided percutaneous cordotomy in ... Fourteen patients with cancer pain underwent CT-guided percutaneous cordotomy. Pain relief was reported in 86% of the patients. The visual ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1472029919301882

Percutaneous cervical cordotomy for cancer-related pain 8 Our more recent yet unpublished prospective outcomes data (2016–2017) re-established the previous findings and confirms that cordotomy is a safe and effective ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2799320/

Five-year follow-up of a cordotomy - PMC - PubMed Central The present report describes a patient who was treated with a right-sided percutaneous cervical cordotomy for refractory cancer pain.