Localized Anal CarcinomaNCT07112690
Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment
A study testing Electronic Health Record Review, Fluoroscopy and Ganglion Impar Neurolysis in people with Localized Anal Carcinoma and Localized Anal Margin Carcinoma, run by Emory University at 2 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Anal Carcinoma, Localized Anal Margin Carcinoma, Stage 0 Anal Cancer AJCC v8
- What is being tested?
- Electronic Health Record Review, Fluoroscopy and Ganglion Impar Neurolysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Nov 2025to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Absolute neutrophil count less than 1500
- Platelet count less 80,000
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Jolinta Y. Lin, 404-778-3473, jolinta.lin@emory.edu
Jolinta Y. Lin
- Recruiting
Grady Health System
Atlanta, Georgia, 30322
Jolinta Lin, MD, 404-778-1900, jolinta.lin@emory.edu
About this study
Official title: Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- 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
- Being tested
- Electronic Health Record Review, Fluoroscopy, Ganglion Impar Neurolysis, Questionnaire Administration
- Medical subject headings
- Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
FluoroscopyProcedure or surgery
Also called Radio Fluoroscopy, Radiographic Fluoroscopy, RF
Undergo fluoroscopy
Ganglion Impar NeurolysisProcedure or surgery
Undergo ganglion impar neurolysis
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (ganglion impar neurolysis) | Experimental | Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study. Receives: Other: Electronic Health Record Review; Procedure: Fluoroscopy; Procedure: Ganglion Impar Neurolysis; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of treatment breaks
Measured: 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.
Measured: At weeks 4, 6, and 18
Secondary outcomes (3)
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.
Measured: At weeks 4, 6, and 18
Narcotic use
Will be assessed using daily narcotic pain medication pill log.
Measured: Up to 6 weeks
Incidence of adverse events
Will be assessed using Common Terminology Criteria for Adverse Events v5.0.
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start10 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Anal CarcinomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jolinta Lin, Emory University
- Investigators
- Jolinta Y. Lin, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112690
- Sponsor's protocol ID
- STUDY00008783
- Other IDs
- NCI-2025-03026, STUDY00008783, WINSHIP6445-24, P30CA138292
- Status last verified
- Jan 2026
- First submitted
- 2 Aug 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
- ClinicalTrials.gov ID
- NCT07112690
- Acronym / sponsor ID
- STUDY00008783
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (ganglion impar neurolysis) | Experimental | Other: Electronic Health Record Review, Procedure: Fluoroscopy, Procedure: Ganglion Impar Neurolysis, Other: Questionnaire AdministrationPatients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Absolute neutrophil count less than 1500
- Platelet count less 80,000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Supportive care (ganglion impar neurolysis) |
| FluoroscopyAlso: Radio Fluoroscopy, Radiographic Fluoroscopy, RFUndergo fluoroscopy | Procedure or surgery | Supportive care (ganglion impar neurolysis) |
| Ganglion Impar NeurolysisUndergo ganglion impar neurolysis | Procedure or surgery | Supportive care (ganglion impar neurolysis) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (ganglion impar neurolysis) |
Primary outcome
Frequency of treatment breaks
Time frame: Up to 6 weeks
Change in pain scores
Time frame: At weeks 4, 6, and 18
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.
3 secondary outcomes
Patient reported outcomes
Time frame: At weeks 4, 6, and 18
Narcotic use
Time frame: Up to 6 weeks
Incidence of adverse events
Time frame: Up to 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jolinta Y. Lin, MD principal investigator
Emory University Hospital/Winship Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Health Record Review, Fluoroscopy and Ganglion Impar Neurolysis in people with Localized Anal Carcinoma and Localized Anal Margin Carcinoma, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jolinta Y. Lin, MD (404-778-1900, jolinta.lin@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment breaks (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.