Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
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.
Detailed 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.
Arms & interventions
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureFluoroscopy
Undergo fluoroscopy
- ProcedureGanglion Impar Neurolysis
Undergo ganglion impar neurolysis
- OtherQuestionnaire Administration
Ancillary studies
Outcome measures
Primary
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
Secondary
Patient reported outcomes
Time frame: At weeks 4, 6, and 18
Narcotic use
Time frame: Up to 6 weeks
Incidence of adverse events
Time frame: Up to 18 weeks
Eligibility criteria
Study locations (2)
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Grady Health System
Atlanta, Georgia, 30322