Clinical trial · Interventional
Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment
Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Anal Carcinoma | Anal Carcinoma | CURATED_BROADER | 0.78 |
| Localized Anal Margin Carcinoma | Anal Margin Carcinoma | CURATED_BROADER | 0.78 |
| Stage 0 Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Anal Cancer AJCC v8 | Malignant Anal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Fluoroscopy | Procedure | — | UNRESOLVED |
| Ganglion Impar Neurolysis | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (ganglion impar neurolysis)
- description
- Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
- interventionNames
- Other: Electronic Health Record Review
- Procedure: Fluoroscopy
- Procedure: Ganglion Impar Neurolysis
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
- Frequency of treatment breaks
- timeFrame
- Up to 6 weeks
- measure
- Change in pain scores
- timeFrame
- At weeks 4, 6, and 18
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available