Baş-Boyun Skuamöz Hücreli Karsinomunda Metformin: Doku Oksijenlenmesi Üzerindeki Etkisi

Sade dilde özet

Bu çalışma, ağız içi skuamöz hücreli karsinom (squamous cell carcinoma) olan hastalarda Metformin adlı ilacın tümör dokusunun oksijenlenmesi üzerindeki etkisini incelemektedir. Çalışmaya, tümör rezeksiyonu (ameliyatla çıkarma) planlanan, ilk tanı almış ve daha önce tedavi görmemiş 18 yaş üzeri hastalar katılmıştır. Çalışma Faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz dışı

Durum

Tamamlandı

Sponsor

Insel Gruppe AG, University Hospital Bern

Müdahale

Metformin

Başlangıç

13.06.2018

Tahmini bitiş

15.11.2021

Ülkeler

Switzerland

İlgili genler

Merkezler

• Bern, Switzerland

Uygunluk kriterleri

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

Inclusion Criteria:

* Patients with biopsy-proven oral cavity squamous cell carcinoma, planned for tumor resection upon institutional tumor board decision.
* Tumor tissue (biopsy) prior to metformin administration available for genetic testing
* Age ≥ 18 years of age.
* First diagnosis, no prior treatment.
* All subjects must be able to comprehend and sign a written informed consent document.
* Informed consent as documented by signature

Exclusion Criteria:

* Pregnancy or lactation.
* Distant metastasis.
* Hypersensitivity to metformin or any of its components.
* Metformin treatment for any reason during the preceding 3 months.
* Diabetic patients regardless of treatment.
* Patients planned for imaging using iodinated contrast dye within 16 days prior to surgery.
* Any concomitant drug contraindicated for use with metformin according to the approved product information.
* Plasma alanine aminotransferase \> 50 IU/dL.
* Plasma aspartate aminotransferase \> 50 IU/dL.
* Estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2.
* Plasma alkaline phosphatase greater than 190 IU/dL.
* History of lactic or any other metabolic acidosis.
* History of diseases potentially causing tissue hypoxia and/or increased risk of lactic acidosis:
* Congestive heart failure.
* Myocardial ischemia within the last 6 months
* Sepsis or severe infection.
* History of lung disease currently requiring any pharmacologic or supplemental oxygen treatment.
* History of hepatic dysfunction or hepatic disease.
* Chronic alcoholism which poses a risk for acute alcohol intoxication at the discretion of the treating physician.
* Scheduled definitive surgical resection less than 10 days from enrollment.
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment, affect patient compliance or place the patient at high risk from treatment-related complication
* Known or suspected non-compliance.
* Participation in another study with investigational drug within the 30 days preceding and during the present study.