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NCT Number: NCT07112690

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Health Record Review

Other

Ancillary studies

Fluoroscopy

Procedure

Undergo fluoroscopy

Other names: Radio Fluoroscopy, Radiographic Fluoroscopy, RF

Ganglion Impar Neurolysis

Procedure

Undergo ganglion impar neurolysis

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Frequency of treatment breaks

    Time frame: Up to 6 weeks

  2. Change in pain scores

    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.

Secondary outcomes

  1. Patient reported outcomes

    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.

  2. Narcotic use

    Time frame: Up to 6 weeks

    Will be assessed using daily narcotic pain medication pill log.

  3. Incidence of adverse events

    Time frame: Up to 18 weeks

    Will be assessed using Common Terminology Criteria for Adverse Events v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Jolinta Y. Lin, MD

CONTACT

[email protected]

404-778-1900

Vinita Singh, MD, MS

CONTACT

[email protected]

404-778-1900

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 8, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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