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

NCT ID: NCT07112690

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-02
• Study Completion Date: 2027-09-30

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (ganglion impar neurolysis)

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

Group Type: EXPERIMENTAL

Electronic Health Record Review

Intervention Type: OTHER

Ancillary studies

Fluoroscopy

Intervention Type: PROCEDURE

Undergo fluoroscopy

Ganglion Impar Neurolysis

Intervention Type: PROCEDURE

Undergo ganglion impar neurolysis

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Electronic Health Record Review

Ancillary studies

Intervention Type: OTHER

Fluoroscopy

Undergo fluoroscopy

Intervention Type: PROCEDURE

Ganglion Impar Neurolysis

Undergo ganglion impar neurolysis

Intervention Type: PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Radio Fluoroscopy; Radiographic Fluoroscopy; RF

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Jolinta Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jolinta Y. Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Grady Health System

Atlanta, Georgia, United States

Countries

United States

Central Contacts

Jolinta Y. Lin, MD

Role: CONTACT

jolinta.lin@emory.edu

404-778-1900

Vinita Singh, MD, MS

Role: CONTACT

vinita.singh@emory.edu

404-778-1900

Facility Contacts

Jolinta Y. Lin

Role: primary

jolinta.lin@emory.edu

404-778-3473

Jolinta Lin, MD

Role: primary

jolinta.lin@emory.edu

404-778-1900

Other Identifiers

NCI-2025-03026

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00008783

Identifier Type: OTHER

Identifier Source: secondary_id

WINSHIP6445-24

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008783

Identifier Type: -

Identifier Source: org_study_id