Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: a single centre, phase II/III, randomized, double blinded, placebo controlled clinical trial

Faculty of Medicine, University of Colombo0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•a) Patients with histologically proven differentiated papillary and follicular thyroid cancer following total thyroidectomy and are eligible for RAI therapy, referred to the National Institute of Cancer, Sri Lanka will be invited to participate in this study.
•b) Without any history of radiotherapy
•c) Age >18 years
•d) An ECOG performance status score of 0-1
•e) Patients must have normal marrow function as defined below:
•leukocytes >3,000/mcL
•absolute neutrophil count >1,500/mcL
•platelets >100,000/mcL
•f) In females of the reproductive age group, exclusion of pregnancy before commencing RAI and avoiding future pregnancy for 6 months using contraceptives is mandatory. Therefore, such patients who are capable of child bearing on adequate contraception will be included in this study.
•g) Available for follow up and management in the study centre for at least 6 months
•h) Informed, voluntary, written consent
•i) Patients must sufficiently understand English, Sinhala or Tamil to fill in the quality of life and patient reported outcome measures.

排除标准

•a). Those with absolute and relative contraindications for glucocorticoids such as uncontrolled diabetes mellitus, gastric and duodenal ulcers, immunosuppression, ongoing or active infections, chronic infective diseases
•b). History of previous RAI therapy
•c). Previous major head and neck surgery
•d). Patients with severe debilitating diseases that can affect the quality of life.
•e). Patients with previous history of salivary gland diseases such as sialadenitis, duct obstruction, calculi, and ophthalmological diseases such as xerophthalmia and conjunctivitis
•f) Uncontrolled concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations (within 12 months before study) that would limit compliance with study requirements.
•g) Pregnant women and breast feeding mothers are excluded as RAI therapy is contraindicated in such patients.
•h) Diagnosed HIV-positive patients on combination antiretroviral therapy are ineligible as glucocorticoids may further suppress the immunity and increase the chances of opportunistic infection
•i) Prior diagnosis of cancer that was:
•More than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
•Within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix

研究者

发起方

Faculty of Medicine, University of Colombo

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