Effect of Beta Glucan on Oncological Outcomes in Cervical Cancer Patients Undergoing Concurrent Chemoradiation: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Faculty of Medicine, Prince of Songkla University0 个研究点目标入组 286 人开始时间: 2022年2月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Patients must have:
•- Cervical cancer FIGO stage IB2-IVA (FIGO 2018)
•- Histopathology of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma
•- ECOG performance status 0-2
•- No history of other cancer
•- Adequate bone marrow function (WBC > or = 3,000/mm3, granulocytes > or = 1,500/mm3, platelet count > or = 100,000/mm3)
•- Bilirubin < 1.5 folds, SGOT/ SGPT < 1.5 folds of normal limit, creatinine clearance > or = 40 mg/dl
•- Be willing and have the ability to comply with scheduled visits (including geographical proximity), treatment plans, laboratory tests, and other study procedures

•- has received prior systemic chemotherapy or radiotherapy at any time for cervical cancer
•- Para-aortic lymph node enlargement > 1 cm or suspicious for cancer metastasis from CT or MRI
•- Chronic illnesses e.g. renal failure/ impairment, peripheral or central neuropathy, uncontrolled diabetes mellitus, or HIV infection.
•- Pregnancy or lactation
•- Patients with infection or inflammatory conditions or on oral/topical antimicrobials or use antiseptic solution for vaginal wash in the past 3 weeks.
•- had previous exposure to beta glucan products.
•- Allergy to the study drugs

发起方

Faculty of Medicine, Prince of Songkla University