Ganglion impar nerve block to reduce radiation pain during treatment for anal or perianal cancer
Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
This will try a ganglion impar nerve block to reduce radiation-related pain in adults getting chemoradiation for localized anal or perianal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT07112690 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with localized anal or perianal cancer undergoing definitive chemoradiation who report persistent moderate to severe pain (for example, pain scores ≥ 5) are ideal candidates.
Not a fit: Patients without significant radiation-related pain, those with widespread metastatic disease, or patients who cannot safely undergo the nerve block procedure are unlikely to benefit.
Why it matters
Potential benefit: If successful, patients may experience less radiation-related pain and fewer unplanned interruptions to their cancer treatment.
How similar studies have performed: Ganglion impar neurolysis has been used for perineal and pelvic pain with reports of pain relief, but there are limited data specific to use during concurrent chemoradiation for anal cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Atlanta, Georgia and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.