Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07112690

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

Led by Emory University · Updated on 2026-01-30

5

Participants Needed

2

Research Sites

98 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with localized anal or perianal skin cancer and either started or about to start definitive chemotherapy and radiation therapy
  • Reporting pain scores of 5 or higher, or experiencing high pain interference or distress
  • At least 18 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (Karnofsky score over 60%)
  • Life expectancy greater than 12 months
  • Able to understand and willing to sign informed consent
  • Men and women of all races and ethnic groups are eligible
  • Willing and able to complete questionnaires
  • Previous cancer diagnosis such as colon or previously resected anal cancer allowed
  • HIV diagnosis or immunocompromised status allowed
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Grady Health System

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

J

Jolinta Y. Lin, MD

CONTACT

V

Vinita Singh, MD, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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