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

RecruitingNAAges 18 Years - anyAllEmory University
NCT07112690 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 radi

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Absolute neutrophil count less than 1500 * Platelet count less 80,000
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What it tests

  • Electronic Health Record Review
  • Fluoroscopy
  • Ganglion Impar Neurolysis
  • Questionnaire Administration
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Where

2 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, United States
Grady Health System
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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