Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Frequency of treatment breaks
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Absolute neutrophil count less than 1500
- •Platelet count less 80,000
研究组 & 干预措施
Supportive care (ganglion impar neurolysis)
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
干预措施: Electronic Health Record Review (Other)
Supportive care (ganglion impar neurolysis)
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
干预措施: Fluoroscopy (Procedure)
Supportive care (ganglion impar neurolysis)
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
干预措施: Ganglion Impar Neurolysis (Procedure)
Supportive care (ganglion impar neurolysis)
Patients undergo ganglion impar neurolysis with fluoroscopy during week 4 of CRT on study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Frequency of treatment breaks
时间窗: Up to 6 weeks
Change in pain scores
时间窗: 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.
次要结局
- Patient reported outcomes(At weeks 4, 6, and 18)
- Incidence of adverse events(Up to 18 weeks)
- Narcotic use(Up to 6 weeks)
研究者
Jolinta Lin
Principal Investigator
Emory University