Ganglion Impar Neurolysis for Pain in Anal Cancer

Not yet recruiting at 1 trial location

Overseen By Vinita Singh, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Low neutrophil, low platelet, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to reduce pain from radiation treatment in individuals with anal or perianal skin cancer. The treatment, ganglion impar neurolysis, involves injecting medicine near the tailbone to numb specific nerves and reduce pain. It targets patients undergoing chemotherapy and radiation therapy who experience significant pain impacting their daily life. As an unphased trial, this study provides patients the chance to explore innovative pain management techniques that could greatly enhance their quality of life.

Do I have to stop taking 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 ganglion impar neurolysis is safe for treating radiation-induced pain in anal cancer?

Research has shown that ganglion impar neurolysis is generally safe and well-tolerated for managing pain, with studies indicating few side effects. This procedure involves injecting medicine near the tailbone to numb nerves in the lower back and genital area, helping to relieve pain. Specifically, when used for pain in the perineal area, ganglion impar neurolysis has effectively reduced long-term pain with minimal risks. Overall, it appears to be a safe option for those experiencing severe pain related to cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for anal cancer, which often focus on chemotherapy and radiation, ganglion impar neurolysis targets pain management directly by disrupting pain signals at a specific nerve cluster. Researchers are excited about this approach because it offers a non-opioid option for alleviating cancer-related pain, potentially reducing the need for narcotic painkillers and their associated side effects. Additionally, the use of fluoroscopy during the procedure ensures precise delivery, which could enhance effectiveness and minimize risks.

What evidence suggests that ganglion impar neurolysis is effective for radiation-induced pain in anal cancer?

Research has shown that ganglion impar neurolysis, which participants in this trial will receive, can help manage pain in people with cancer-related pelvic issues. This procedure involves injecting medicine near the tailbone to block pain signals. Studies have found that about 66.6% of patients experienced more than a 50% reduction in pain. The pain relief from this procedure can last for about three months, making it a promising option for those experiencing pain from radiation during anal cancer treatment. ^{1 3 4 5 6}

Who Is on the Research Team?

Jolinta Y. Lin, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with localized anal or perianal skin cancer experiencing pain from radiation therapy. Participants should be undergoing chemotherapy and radiation but have not had the cancer spread to other body parts.

Inclusion Criteria

Life expectancy of greater than 12 months

I regularly experience pain at a level of 5 or higher.

I have localized anal or perianal skin cancer and am starting or about to start chemo and radiation.

Exclusion Criteria

Absolute neutrophil count less than 1500

Platelet count less 80,000

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiotherapy (CRT)

Participants receive concurrent chemotherapy and radiation therapy for anal or perianal skin cancer

6 weeks

Weekly visits for treatment

Ganglion Impar Neurolysis

Participants undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT to manage radiation-induced pain

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain scores and patient-reported outcomes

12 weeks

Visits at weeks 6 and 18

What Are the Treatments Tested in This Trial?

Interventions

• Ganglion Impar Neurolysis

Trial Overview

The study tests ganglion impar neurolysis, a nerve block procedure aiming to reduce radiation-induced pain during treatment. It involves injecting medicine near the tailbone to numb nerves affecting sensation in nearby skin areas.

How Is the Trial Designed?

Group I: Supportive care (ganglion impar neurolysis) Experimental Treatment 4 Interventions

Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7036554/

Ganglion Impar Neurolysis in the Management of Pelvic ...

Pain control was achieved for 3 months with the first ganglion impar neurolysis, which is consistent with the median duration of benefit ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2341192924000817

Ganglion impar block in chronic cancer-related pain

Ganglion impar block is a useful tool in the management of intractable perineal oncologic or sequelae perineal and/or pelvic pain.

3.

phcogj.com

phcogj.com/sites/default/files/PharmacognJ-16-3-711.pdf

Ganglion Impar Block and Neurolysis for Perineal Pain in ...

The pain can significantly reduce a patient's quality of life and there is currently no effective treatment for it. Ganglion impar block and ...

4.

medsci.org

medsci.org/v18p2957.htm

Factors associated with Successful Responses to Ganglion ...

They found that successful response, defined as lowering of the pre-procedural visual analogue scale by more than 50%, occurred in 66.6% of patients with pelvic ...

5.

ctv.veeva.com

ctv.veeva.com/study/ganglion-impar-neurolysis-for-the-improvement-of-radiation-induced-pain-during-localized-anal-or-per

Ganglion Impar Neurolysis for the Improvement of Radiation ...

This clinical trial studies how well ganglion impar neurolysis works to improve radiation-induced pain during the treatment of anal or ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07112690

Study Details | NCT07112690 | Ganglion Impar Neurolysis ...

This clinical trial studies how well ganglion impar neurolysis works to improve radiation-induced pain during the treatment of anal or perianal skin cancer that ...