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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-03026 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00008783 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| WINSHIP6445-24 | Other Identifier | Emory University Hospital/Winship Cancer Institute | |
| P30CA138292 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of ganglion impar neurolysis on decreasing pain in patients undergoing definitive CRT for anal cancer defined as decreasing unscheduled treatment breaks to a median of ≤ 3 days.
SECONDARY OBJECTIVE:
I. To track toxicities and patient-reported outcomes (PRO) during treatment including intervention of ganglion impar neurolysis.
OUTLINE:
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
After completion of study intervention, patients are followed up during the last week of radiation therapy and at 3-6 months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (ganglion impar neurolysis) | Experimental | Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Health Record Review | Other | Ancillary studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of treatment breaks | Up to 6 weeks | |
| Change in pain scores | 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. | At weeks 4, 6, and 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported outcomes | Will be assessed using European Organization for Research and Treatment of Cancer Colorectal Cancer Specific Quality of Life Questionnaire and Anal Cancer Questionnaire. | At weeks 4, 6, and 18 |
| Narcotic use |
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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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolinta Y. Lin, MD | Contact | 404-778-1900 | jolinta.lin@emory.edu | |
| Vinita Singh, MD, MS | Contact | 404-778-1900 | vinita.singh@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jolinta Y. Lin, MD | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Fluoroscopy |
| Procedure |
Undergo fluoroscopy |
|
|
| Ganglion Impar Neurolysis | Procedure | Undergo ganglion impar neurolysis |
|
| Questionnaire Administration | Other | Ancillary studies |
|
Will be assessed using daily narcotic pain medication pill log.
| Up to 6 weeks |
| Incidence of adverse events | Will be assessed using Common Terminology Criteria for Adverse Events v5.0. | Up to 18 weeks |
| Grady Health System | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| ID | Term |
|---|---|
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
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