Ganglion impar nerve block to reduce radiation pain during treatment for anal or perianal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with localized anal or perianal cancer receiving definitive concurrent chemotherapy and radiation who report significant pain will undergo a fluoroscopy-guided ganglion impar neurolysis in week 4 of treatment. The procedure injects medication around the ganglion impar near the tailbone to numb nerves supplying the perineal and anal skin. The main goal is to lower unscheduled treatment breaks to a median of ≤ 3 days by reducing pain, while secondary measures track toxicities and patient-reported outcomes. Patients are followed during the final week of radiation and again at 3 to 6 months after treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Grady Health System
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Jolinta Y. Lin, MD — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Jolinta Y. Lin, MD
• Email: jolinta.lin@emory.edu
• Phone: 404-778-1900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.