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.
- Conditions
- Differentiated Thyroid cancer
- Registration Number
- SLCTR/2020/009
- Lead Sponsor
- Faculty of Medicine, University of Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the impact of glucocorticoids on the incidence of predefined clinically significant early/intermediate adverse effects of RAI (according to the Common Terminology Criteria for Adverse Events v4.0)between patients treated with prophylactic prednisolone versus placebo [2 weeks and 3 months after completion of RAI]<br>
- Secondary Outcome Measures
Name Time Method