NCT07112690

Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment

Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 has not spread to other parts of the body (localized). Treatment for anal or perianal skin cancer includes giving chemotherapy and radiation therapy (CRT) at the same time. CRT is frequently associated with several side effects, including radiation-induced pain. Despite advances in radiation therapy delivery, patients may still experience side effects which can lead to treatment breaks or treatment discontinuation. Ganglion impar neurolysis is a type of nerve block procedure in which medicine is injected directly into or around a nerve to block pain. The location of the procedure is near the tail bone and the medicine numbs the nerves that are in charge of sensation in the skin by the buttocks and genitalia. This may improve radiation-induced pain in patients receiving CRT for localized anal or perianal skin cancer.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of ganglion impar neurolysis on decreasing pain in patients undergoing definitive CRT for anal cancer defined as decreasing unscheduled treatment breaks to a median of ≤ 3 days. SECONDARY OBJECTIVE: I. To track toxicities and patient-reported outcomes (PRO) during treatment including intervention of ganglion impar neurolysis. OUTLINE: Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study. After completion of study intervention, patients are followed up during the last week of radiation therapy and at 3-6 months post-treatment.

Conditions

• Localized Anal Carcinoma
• Localized Anal Margin Carcinoma
• Stage 0 Anal Cancer AJCC v8
• Stage I Anal Cancer AJCC v8
• Stage II Anal Cancer AJCC v8
• Stage IIIB Anal Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Electronic Health Record Review	Ancillary studies
PROCEDURE	Fluoroscopy	Undergo fluoroscopy
PROCEDURE	Ganglion Impar Neurolysis	Undergo ganglion impar neurolysis
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2025-11-10
• Primary completion: 2026-09-30
• Completion: 2027-09-30
• First posted: 2025-08-08
• Last updated: 2026-01-30

Locations

2 sites across 1 country: United States