Differentiated Thyroid cancer
Conditions
Interventions
Study Setting: Apeksha Hospital (National Institute of Cancer), Maharagam, Sri Lanka.
After obtaining informed written consent from patients who accept the invitation, they will be randomized to eith
Sponsors
Faculty of Medicine, University of Colombo
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To estimate the impact of glucocorticoids on the proportion of patients developing early and intermediate adverse effects due to RAI in the first 3 months after completion of RAI (all types, all grades, any duration) [3 months] 2. To describe comparatively between treatment and control groups, the onset, recurrence, duration and severity of early and intermediate adverse effects of RAI in the first 3 months after completion of RAI [ 3 months] 3. To estimate the impact of glucocorticoids in terms of the incidence, severity, duration and type of adverse events assessed in relation to glucocorticoids [ 3 months] 4. To evaluate the impact of glucocorticoids on the patient reported outcomes related to adverse effects of RAI and/or glucocorticoids at 2 weeks and 3 months after completion of RAI [ 2 weeks and 3 months] 5. To evaluate the impact on the quality of life (Euro-Qol (EQ-5D-5L) and Functional Assessment of Cancer Therapy-Head and Neck (FACT H&N)), first, overall between treatment groups, then focusing on patients who have experienced a complication of RAI. [ 2 weeks and 3 months] | — |
Countries
Sri Lanka
Contacts
Public ContactUmesh Jayarajah
Registrar in Surgery
Outcome results
None listed