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NCT Number: NCT07112690
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ancillary studies
Undergo fluoroscopy
Other names: Radio Fluoroscopy, Radiographic Fluoroscopy, RF
Undergo ganglion impar neurolysis
Ancillary studies
Time frame: Up to 6 weeks
Time frame: At weeks 4, 6, and 18
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
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: Up to 6 weeks
Will be assessed using daily narcotic pain medication pill log.
Time frame: Up to 18 weeks
Will be assessed using Common Terminology Criteria for Adverse Events v5.0.
Contact information is provided by the study sponsor or research team.
Jolinta Y. Lin, MD
CONTACT
Vinita Singh, MD, MS
CONTACT
Emory University
Other
Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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