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

NCT07112690 | Recruiting DMC

• 4 other identifiers: STUDY00008783NCI-2025-03026WINSHIP6445-24P30CA138292
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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; Stage IIIB Anal Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Frequency of treatment breaks

  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.

  At weeks 4, 6, and 18

Secondary Outcomes (3)

• Patient reported outcomes

  At weeks 4, 6, and 18

• Narcotic use

  Up to 6 weeks

• Incidence of adverse events

  Up to 18 weeks

Study Arms (1)

Supportive care (ganglion impar neurolysis)

EXPERIMENTAL

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

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (ganglion impar neurolysis)

Fluoroscopy PROCEDURE

Undergo fluoroscopy

Also known as: Radio Fluoroscopy, Radiographic Fluoroscopy, RF

Supportive care (ganglion impar neurolysis)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (ganglion impar neurolysis)

Ganglion Impar Neurolysis PROCEDURE

Undergo ganglion impar neurolysis

Supportive care (ganglion impar neurolysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Absolute neutrophil count less than 1500
• Platelet count less 80,000

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Grady Health System

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Jolinta Y. Lin, MD

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jolinta Y. Lin, MD

CONTACT

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

Vinita Singh, MD, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

US (2)