Post-Operative Dosing of Dexamethasone in Patients With Brain Tumors After a Craniotomy, PODS Trial
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: Biospecimen Collection, Computed Tomography, Dexamethasone, Magnetic Resonance Imaging.
- Кому может быть актуально
- Состояния в реестре: Low Grade Glioma, Malignant Brain Glioma, Malignant Brain Neoplasm, Meningioma. 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
Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS)
Обзор
This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.
Подробное описание
PRIMARY OBJECTIVES:
I. The primary objective of this study is to evaluate the efficacy of a reduced dosage steroid schedule (RDS) in patients who have undergone craniotomy for high grade glioma (HGG), low grade glioma (LGG), brain metastasis (BM), and meningiomas as compared with the normal dosing schedule (NDS).
II. RDS after undergoing craniotomy for brain tumor has no impact on length of stay, 30 day readmission, and need for repeat imaging when compared to NDS.
SECONDARY OBJECTIVE:
I. RDS after craniotomy for brain tumor has no impact on development of steroid related side effects (new onset or worsening hypertension, hyperglycemia, wound infection, impaired wound healing, steroid dependence, neuropsychiatric disturbance) when compared to NDS.
TERTIARY/EXPLORATORY OBJECTIVE:
I. RDS after craniotomy has no effect on lymphocyte count and differential at 10-14 days after surgery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (NDS): Patients receive tapering doses of dexamethasone on days 1-15. Patients also undergo blood sample collection at time of surgery, at follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo magnetic resonance imaging (MRI) and computed tomography (CT) scan during inpatient stay as part of standard of care.
ARM II (RDS): Patients receive tapering doses of dexamethasone on days 1-4. Patients may receive dexamethasone intravenously (IV) and restart the taper if clinically indicated. Patients also undergo blood sample collection at time of surgery, follow up visits and optionally at wound check visit 10-14 days post operative at investigator availability. Patients additionally undergo MRI and CT scan during inpatient stay as part of standard of care.
Вмешательства
- Процедура Biospecimen Collection
Undergo blood sample collection - Процедура Computed Tomography
Undergo CT scan - Препарат Dexamethasone
Given dexamethasone or IV - Процедура Magnetic Resonance Imaging
Undergo MRI - Другое Questionnaire Administration
Ancillary studies
Первичные конечные точки
- Length of hospital stay [Срок оценки: Up to 3 months]
- 30-day repeat admission rate [Срок оценки: At 30 days after surgery]
- Need for repeat head imaging [Срок оценки: Up to 3 months]
Вторичные конечные точки (9)
- Incidence of new neurologic deficit [Срок оценки: At less than 30 days and at 3 months]
- Breakthrough seizures [Срок оценки: Up to 30 days after surgery]
- Evidence of Worsening Cerebral Edema [Срок оценки: Between 5 and 30 days after surgery]
- Evaluation for Steroid Dependence [Срок оценки: At long term follow up to 3 months after surgery]
- Rate of new onset hypertension [Срок оценки: During inpatient stay up to 3 months after surgery]
- Rate of new onset hyperglycemia [Срок оценки: During inpatient stay up to 3 months after surgery]
- Evaluation for Wound infection or Delayed Wound Healing [Срок оценки: At 2 week wound check after surgery]
- Evaluation for Need for Psychiatric Consult or Neuropsychiatric Side Effects [Срок оценки: At 2 week follow up after surgery]
- Change in lymphocyte count and differential [Срок оценки: At baseline and 10-14 days post-operative]
Критерии участия
Критерии включения
- Patients with radiographic findings consistent with either HGG, LGG, Meningioma, or brain metastasis
- Age equal to or above 18
Критерии исключения
- Known hypothalamic-pituitary-adrenal (HPA) axis dysfunction
- Tumor causing compression of the sella or pituitary dysfunction
- Known immunodeficiency - including but not limited to severe combined immunodeficiency (SCID), common variable immunodeficiency (CVID), lymphocytopenia
- Taking immunosuppressive drugs - including but not limited to methotrexate, mycophenolate, rapamycin, tacrolimus, adalimumab, infliximab. Greater than two weeks of recent daily corticosteroid use or the use of corticosteroids equivalent to > 85 mg of dexamethasone in the last month
- Current lymphoma or leukemia
- History of solid organ transplant
- Minors < 18
- Pregnant women
- History of cerebrovascular accident leading to neurologic deficit
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Emory University Hospital/Winship Cancer Institute — Atlanta
Идентификаторы
NCT: NCT06132685 · STUDY00003975 · NCI-2023-04702 · STUDY00003975 · WINSHIP5678-22 · P30CA138292