Идёт набор NCT07112690

Ganglion Impar Neurolysis for the Improvement of Radiation-Induced Pain During Localized Anal or Perianal Skin Cancer Treatment

Без фазы С лечением Localized Anal Carcinoma Localized Anal Margin Carcinoma Stage 0 Anal Cancer AJCC v8 Stage I Anal Cancer AJCC v8

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Electronic Health Record Review, Fluoroscopy, Ganglion Impar Neurolysis, Questionnaire Administration.
Кому может быть актуально: Состояния в реестре: Localized Anal Carcinoma, Localized Anal Margin Carcinoma, Stage 0 Anal Cancer AJCC v8, Stage I Anal Cancer AJCC v8. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Ganglion Impar Neurolysis for Radiation-Induced Pain During Anal Cancer Treatment

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Electronic Health Record Review
Ancillary studies
Процедура Fluoroscopy
Undergo fluoroscopy
Процедура Ganglion Impar Neurolysis
Undergo ganglion impar neurolysis
Другое Questionnaire Administration
Ancillary studies

Первичные конечные точки

Frequency of treatment breaks [Срок оценки: Up to 6 weeks]
Change in pain scores [Срок оценки: At weeks 4, 6, and 18]

Вторичные конечные точки (3)

Patient reported outcomes [Срок оценки: At weeks 4, 6, and 18]
Narcotic use [Срок оценки: Up to 6 weeks]
Incidence of adverse events [Срок оценки: Up to 18 weeks]

Критерии участия

Критерии включения

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