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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients must have diagnosis of localized anal cancer or perianal skin cancer and have either initiated or about to initiated definitive chemotherapy and radiation therapy for their cancer

⁃ Patients who are consistently reporting pain scores of 5 or higher or reporting high pain interference or distress will be approached to participate in the study

• Age \> 18 years. Given the rarity of anal cancer in children, children are excluded from this study

• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \> 60%)

• Life expectancy of greater than \> 12 months

• Ability to understand and the willingness to sign a written informed consent document

• Inclusion of women and minorities: Both men and women and members of all races and ethnic groups are eligible for this trial

• Willingness and ability of the subject to complete the questionnaire

• Previous cancer diagnosis (such as colon or previously resected anal cancer) is permitted

• A diagnosis of HIV or immunocompromised status is permitted

Locations
United States
Georgia
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Grady Health System
RECRUITING
Atlanta
Contact Information
Primary
Jolinta Y. Lin, MD
jolinta.lin@emory.edu
404-778-1900
Backup
Vinita Singh, MD, MS
vinita.singh@emory.edu
404-778-1900
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 5
Treatments
Experimental: Supportive care (ganglion impar neurolysis)
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
Sponsors
Leads: Emory University
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov