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

Phase

N/A

Condition

Anal Dysplasia

Carcinoma

Treatment

Fluoroscopy

Questionnaire Administration

Electronic Health Record Review

Clinical Study ID

NCT07112690

STUDY00008783

P30CA138292

STUDY00008783

WINSHIP6445-24

NCI-2025-03026

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Patients must have diagnosis of localized anal cancer or perianal skin cancer andhave either initiated or about to initiated definitive chemotherapy and radiationtherapy for their cancer
Patients who are consistently reporting pain scores of 5 or higher or reportinghigh pain interference or distress will be approached to participate in thestudy
Age > 18 years. Given the rarity of anal cancer in children, children are excludedfrom 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 consentdocument
Inclusion of women and minorities: Both men and women and members of all races andethnic 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) ispermitted
A diagnosis of HIV or immunocompromised status is permitted

Exclusion

Exclusion Criteria:

Absolute neutrophil count less than 1500
Platelet count less 80,000

Study Design

Fluoroscopy

November 10, 2025

September 30, 2027

Study 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.

Connect with a study center

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Site Not Available
Grady Health System
Atlanta, Georgia 30322
United States
Site Not Available
Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
United States
Active - Recruiting
Grady Health System
Atlanta 4180439, Georgia 4197000 30322
United States
Active - Recruiting

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