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

Not Applicable

Not yet recruiting

• Conditions: Localized Anal Carcinoma; Localized Anal Margin Carcinoma; Stage 0 Anal Cancer AJCC v8; Stage I Anal Cancer AJCC v8; Stage II Anal Cancer AJCC v8; Stage IIIB Anal Cancer AJCC v8

• Registration Number: NCT07112690
• Lead Sponsor: Emory University

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-02
• Study First Submitted QC: 2025-08-02
• Last Update Submitted: 2025-08-02
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-09-02
• Primary Completion: 2025-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of treatment breaks	Up to 6 weeks
Change in pain scores	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.

Secondary Outcome Measures

Name	Time	Method
Patient reported outcomes	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.
Incidence of adverse events	Up to 18 weeks	Will be assessed using Common Terminology Criteria for Adverse Events v5.0.
Narcotic use	Up to 6 weeks	Will be assessed using daily narcotic pain medication pill log.

Trial Locations

Locations (2)

Emory University Hospital/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Grady Health System; 🇺🇸 Atlanta, Georgia, United States