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Official Title

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

Sponsor
Emory University
Enrollment
5
Timeline
Dec 2025 → Sep 2027
About This Study

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 Criteria

  • 1Patients 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
  • 2Patients 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
  • 3Age \> 18 years. Given the rarity of anal cancer in children, children are excluded from this study
  • 4Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \> 60%)
  • 5Life expectancy of greater than \> 12 months
  • 6Ability to understand and the willingness to sign a written informed consent document
  • 7Inclusion of women and minorities: Both men and women and members of all races and ethnic groups are eligible for this trial
  • 8Willingness and ability of the subject to complete the questionnaire
  • 9Previous cancer diagnosis (such as colon or previously resected anal cancer) is permitted
  • 10A diagnosis of HIV or immunocompromised status is permitted

Exclusion Criteria

  • 1Absolute neutrophil count less than 1500
  • 2Platelet count less 80,000

Locations

2 sites participating in this study

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Jolinta Y. Lin

Grady Health System

Atlanta, Georgia 30322

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →