Ganglion Impar Neurolysis for Radiation Pain in Anal Cancer

This study is looking at whether a procedure called ganglion impar neurolysis can help reduce pain caused by radiation treatment for localized anal or perianal skin cancer. Localized means the cancer has not spread. When you receive chemotherapy and radiation therapy (CRT) for this type of cancer, you might experience pain. This pain can sometimes lead to breaks in treatment or even stopping treatment altogether. Ganglion impar neurolysis involves injecting medicine near a nerve to block pain. The study aims to see if this procedure can decrease the number of unplanned treatment breaks and improve your pain scores. You might be able to join if you have localized anal or perianal skin cancer, are starting or have started CRT, and consistently report pain scores of 5 or higher.

Study design
This is an interventional study with a planned enrollment of 5 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo ganglion impar neurolysis with fluoroscopy (a type of X-ray) during week 4 of your chemotherapy and radiation therapy. You would also complete questionnaires and have your electronic health records reviewed.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up during the last week of radiation therapy and again 3-6 months after treatment.

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NCT07112690

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

Recruiting
NAAges 18+InterventionalSupportive care
Emory University
~5 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:Electronic Health Record ReviewFluoroscopyGanglion Impar NeurolysisQuestionnaire Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of treatment breaks
Measured over Up to 6 weeks
+1 more outcome measured
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
2 sites across 1 states
Georgia2
  • Jolinta Y. Lin, MD · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

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Eligibility criteria

Inclusion

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

Absolute neutrophil count less than 1500
Platelet count less 80,000
  • Frequency of treatment breaksUp to 6 weeks
  • Change in pain scoresAt 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.