[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07112690":3,"trial-entities:NCT07112690":132,"trial-summary:NCT07112690":137},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":55,"secondary_outcomes":63,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":94,"locations":97,"central_contacts":122,"overall_officials":128,"references":130,"see_also_links":131},"NCT07112690","STUDY00008783","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","RECRUITING","2027-09-30","2026-01","2026-01-30","2025-11-10","Emory University","OTHER",true,"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:\n\nI. 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.\n\nSECONDARY OBJECTIVE:\n\nI. To track toxicities and patient-reported outcomes (PRO) during treatment including intervention of ganglion impar neurolysis.\n\nOUTLINE:\n\nPatients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.\n\nAfter completion of study intervention, patients are followed up during the last week of radiation therapy and at 3-6 months post-treatment.",[19,20,21,22,23,24],"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",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},5,"ESTIMATED",[34,39,48,52],{"type":14,"name":35,"description":36,"armGroupLabels":37},"Electronic Health Record Review","Ancillary studies",[38],"Supportive care (ganglion impar neurolysis)",{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"PROCEDURE","Fluoroscopy","Undergo fluoroscopy",[38],[45,46,47],"Radio Fluoroscopy","Radiographic Fluoroscopy","RF",{"type":40,"name":49,"description":50,"armGroupLabels":51},"Ganglion Impar Neurolysis","Undergo ganglion impar neurolysis",[38],{"type":14,"name":53,"description":36,"armGroupLabels":54},"Questionnaire Administration",[38],[56,59],{"measure":57,"timeFrame":58},"Frequency of treatment breaks","Up to 6 weeks",{"measure":60,"description":61,"timeFrame":62},"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",[64,67,70],{"measure":65,"description":66,"timeFrame":62},"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.",{"measure":68,"description":69,"timeFrame":58},"Narcotic use","Will be assessed using daily narcotic pain medication pill log.",{"measure":71,"description":72,"timeFrame":73},"Incidence of adverse events","Will be assessed using Common Terminology Criteria for Adverse Events v5.0.","Up to 18 weeks","ALL","18 Years",null,false,{"inclusion":79,"exclusion":90,"raw_text":93},[80,81,82,83,84,85,86,87,88,89],"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 =\\\u003C 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",[91,92],"Absolute neutrophil count less than 1500","Platelet count less 80,000","Inclusion Criteria:\n\n* 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\n\n  * 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\n* Age \\> 18 years. Given the rarity of anal cancer in children, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\> 60%)\n* Life expectancy of greater than \\> 12 months\n* Ability to understand and the willingness to sign a written informed consent document\n* Inclusion of women and minorities: Both men and women and members of all races and ethnic groups are eligible for this trial\n* Willingness and ability of the subject to complete the questionnaire\n* Previous cancer diagnosis (such as colon or previously resected anal cancer) is permitted\n* A diagnosis of HIV or immunocompromised status is permitted\n\nExclusion Criteria:\n\n* Absolute neutrophil count less than 1500\n* Platelet count less 80,000",[95,96],"ADULT","OLDER_ADULT",[98,115],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":104,"geoPoint":112},"Emory University Hospital\u002FWinship Cancer Institute","Atlanta","Georgia","30322","United States",[105,110],{"name":106,"role":107,"phone":108,"email":109},"Jolinta Y. Lin","CONTACT","404-778-3473","jolinta.lin@emory.edu",{"name":106,"role":111},"PRINCIPAL_INVESTIGATOR",{"lat":113,"lon":114},33.749,-84.38798,{"facility":116,"status":8,"city":100,"state":101,"zip":102,"country":103,"contacts":117,"geoPoint":121},"Grady Health System",[118],{"name":119,"role":107,"phone":120,"email":109},"Jolinta Lin, MD","404-778-1900",{"lat":113,"lon":114},[123,125],{"name":124,"role":107,"phone":120,"email":109},"Jolinta Y. Lin, MD",{"name":126,"role":107,"phone":120,"email":127},"Vinita Singh, MD, MS","vinita.singh@emory.edu",[129],{"name":124,"affiliation":99,"role":111},[],[],{"nct_id":4,"conditions":133,"biomarkers":136},[134,135],"Anal Carcinoma","Perianal Skin Cancer",[],{"nct_id":4,"found":15,"summary":138,"prompt_version":148},{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an interventional study with a planned enrollment of 5 participants. It is not specified if it is randomized or blinded.","completed","Ganglion Impar Neurolysis for Radiation Pain in Anal Cancer","This study is looking at whether a procedure called ganglion impar neurolysis can help reduce pain caused by radiation treatment for localized anal or perianal skin cancer. Localized means the cancer has not spread. When you receive chemotherapy and radiation therapy (CRT) for this type of cancer, you might experience pain. This pain can sometimes lead to breaks in treatment or even stopping treatment altogether. Ganglion impar neurolysis involves injecting medicine near a nerve to block pain. The study aims to see if this procedure can decrease the number of unplanned treatment breaks and improve your pain scores. You might be able to join if you have localized anal or perianal skin cancer, are starting or have started CRT, and consistently report pain scores of 5 or higher.","You will be followed up during the last week of radiation therapy and again 3-6 months after treatment.",128,"You would undergo ganglion impar neurolysis with fluoroscopy (a type of X-ray) during week 4 of your chemotherapy and radiation therapy. You would also complete questionnaires and have your electronic health records reviewed.","Not stated in the trial record.",[49],"v2"]