cervical cancer
Conditions
Interventions
experimental group:selenium yeast tablets 200ug/d
control group: Placebo was given to patients in the same way as that of selenim yeast
Sponsors
The Ethics Committee of the Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged from 18 to 70 years old; Patients must have Histologically or cytologically confirmed cervical cancer and diagnosed as IIB phase cervical cancer according to the International Association of Obstetrics and Gynecology (FIGO) 2014 clinical staging standards. (2) PS score 0-1 points. (3) Patients must have a Life Expectancy of greater than 12 weeks. (4) Functions of major organs (haemogram,heart,liver, kidney) are basically normal, White blood count >= 3.5* 10^9/L with neutrophils >= 1.5*10^9/L, platelet count >= 100*10^9/L, and hemoglobin >=90g/L. Total bilirubin <=1.5 times upper limit of normal (ULN) range; alkaline phosphatase(ALP) <= 2.5 times ULN, Transaminases AST (SGOT) and ALT (SGPT) <= 2.5 times ULN, serum creatinine <= 1.2 times ULN; (5) Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: (1) Any evidence of severe or uncontrolled systemic diseases (e.g., unstable respiratory, cardiac, hepatic, or renal disease or other serious internal diseases or uncontrolled infection). (2) Known severe hypersensitivity to cisplatin, selenium yeast or yeast or any of the excipients of this product; (3) Women that are pregnant or breastfeeding. (3) Women who are pregnant or breastfeeding. (4) Grade 3 radiation proctitis and radiation cystitis according to the RTOG classification standard. (5) Patients with 3rd degree bone marrow suppression during concurrent radiotherapy and chemotherapy, and the blood cells still cannot return to normal after treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) of the patients;overall survival (OS);Response to therapy;Adverse reactions; | — |
Countries
??
Contacts
Public ContactLin Lai
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Outcome results
None listed