An interventional study of Electronic Health Record Review and Fluoroscopy in Localized Anal Carcinoma, Localized Anal Margin Carcinoma and Stage 0 Anal Cancer AJCC v8, sponsored by Emory University. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Emory University · Not applicable, Interventional, and Supportive care
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.
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.
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
Exclusion Criteria:
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
Other: Electronic Health Record Review · Procedure: Fluoroscopy · Procedure: Ganglion Impar Neurolysis · Other: Questionnaire Administration
Ancillary studies
Undergo fluoroscopy
Also known as: Radio Fluoroscopy, Radiographic Fluoroscopy, RF
Undergo ganglion impar neurolysis
Ancillary studies
Frequency of treatment breaks
Time frame: Up to 6 weeks
Change in pain scores
Will be assessed using pre- and pos-procedure pain scores as well as Patient Reported Outcomes Measurement Information System (PROMIS)-29 Profile version (v) 2.0 scale, PROMIS Neuropathic Pain Quality 5a questionnaire, and Pain Catastrophizing Scale.
Time frame: At weeks 4, 6, and 18
Patient reported outcomes
Will be assessed using European Organization for Research and Treatment of Cancer Colorectal Cancer Specific Quality of Life Questionnaire and Anal Cancer Questionnaire.
Time frame: At weeks 4, 6, and 18
Narcotic use
Will be assessed using daily narcotic pain medication pill log.
Time frame: Up to 6 weeks
Incidence of adverse events
Will be assessed using Common Terminology Criteria for Adverse Events v5.0.
Time frame: Up to 18 weeks
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