Recruiting

Ganglion Impar Neurolysis

Sponsor:

Emory University

Code:

NCT07112690

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Health Record Review

Fluoroscopy

Ganglion Impar Neurolysis

Questionnaire Administration

Study Details

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.

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

Study ID

NCT07112690

Start date

Nov 10, 2025

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive care (ganglion impar neurolysis)

Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.

Interventions

Electronic Health Record Review

Ancillary studies

Fluoroscopy

Undergo fluoroscopy

Ganglion Impar Neurolysis

Undergo ganglion impar neurolysis

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Frequency of treatment breaks [ Time Frame: Up to 6 weeks ]
  • Change in pain scores [ Time Frame: At weeks 4, 6, and 18 ]

Central Contacts and Locations

Central contacts

Jolinta Y. Lin, MD

404-778-1900jolinta.lin@emory.edu

Vinita Singh, MD, MS

404-778-1900vinita.singh@emory.edu

Locations

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jolinta Y. Lin

404-778-3473jolinta.lin@emory.edu

Principal Investigator:

Jolinta Y. Lin

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jolinta Lin, MD

404-778-1900jolinta.lin@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-01-30.