PDAC Hastalarında Ameliyat Öncesi Propranolol'ün Güvenliği, Etkinliği ve Uygulanabilirliğinin İncelenmesi

Sade dilde özet

Bu çalışma, ameliyat öncesi verilen Propranolol ilacının pankreas kanseri (pancreatic ductal adenocarcinoma, PDAC) hastalarındaki güvenliğini, etkinliğini ve uygulanabilirliğini plaseboya kıyasla incelemektedir. Ameliyatla çıkarılabilir pankreas kanseri şüphesi olan, 18 yaş ve üzeri hastalar katılabilmektedir. Çalışma Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Zealand University Hospital

Müdahale

Propranolol, Placebo

Başlangıç

20.03.2024

Tahmini bitiş

31.12.2035

Ülkeler

Denmark

İlgili genler

Merkezler

• Copenhagen, Denmark
• Køge, Denmark

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Patients with suspected surgically resectable pancreatic cancer
* Indication for surgical treatment with curative intend.
* Provide written informed consent.
* Patients minimum 18 years old.

Women of childbearing potential (WOCBP) are defined as women ranging from the period of menarche till the post-menopausal period, unless permanently sterile (e.g., hysterectomy, bilateral salpingectomy and bilateral oophorectomy). Post-menopause is defined as no menses for 12 months without an alternative medical cause.

WOCBP should use a secure and highly effective birth control (as stated in the "Recommendations related to contraception and pregnancy testing in clinical trials", version 1.1., section 4.1, from the Clinical Trials Facilitation and Coordination Group) during the entire period of the trial. In cases of uncertainty regarding pregnancy, additional pregnancy testing either as highly sensitive serum or urine pregnancy test can be used.

Exclusion Criteria:

* Patients with:
* Chronic hypotension, systolic blood pressure \< 100 mg Hg for women and \< 110 mg Hg for men.
* Bradycardia, pulse \< 50 beats per minute.
* Asthma or chronic obstructive lung disease
* Heart insufficiency with affected (\< 50 %) left ventricle ejection fraction (LVEF), treated or untreated.
* Kidney insufficiency, defined as eGFR \< 20 ml/min.
* Liver insufficiency defined as chronically high liver enzymes or known chronic liver disease (e.g., hepatitis, steatosis, cirrhosis).
* Cor pulmonale
* Cardiogenic shock
* Severe peripheral circulatory disorders
* Known or newly diagnosed current metabolic acidosis (e.g., in recent analysis of arterial puncture).
* Known hypersensitivity to propranolol or to one or more of the excipients.
* Currently untreated pheochromocytoma.
* History of Prinzmetals angina.
* History of sick sinus syndrome or atrioventricular block.
* History of stroke or any previous cardiovascular event.
* History of neoadjuvant oncological treatment for suspected primary pancreatic cancer.
* Recent or present (within 3 months) use of propranolol or any other beta-blocker.
* Recent or present (within 3 months) use of any of the following medications: anxiolytics, calcium channel blockers, beta-adrenergic receptor agonist.
* Medical history that classifies the patient as frail or unsuitable for inclusion by the examining physician.
* Histopathological examination revealing benign lesion.
* Predictable poor compliance, due to pre-existing psychiatric disease, dementia or not able to read or speak sufficient Danish, resulting in not being able to provide a well-informed written consent.