Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment
About this study
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.
- Condition
- 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
- Tested
- Electronic Health Record Review, Fluoroscopy, Ganglion Impar Neurolysis, Questionnaire Administration
- Sponsor
- Emory University
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 18 years
- Study condition: 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
- 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 2
- Absolute neutrophil count less than 1500
- Platelet count less 80,000
Where
2 sites, 2 recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Grady Health System
Atlanta, Georgia, United States
Contact
-
Jolinta Y. Lin, MD
404-778-1900 jolinta.lin@emory.edu
-
Vinita Singh, MD, MS
404-778-1900 vinita.singh@emory.edu
Potential match only. Final eligibility is determined by the study team.