Abstract
BackgroundRadioactive iodine (RAI) therapy is the standard adjuvant treatment for differentiated thyroid cancer (i.e. papillary and follicular). RAI is associated with troublesome early, intermediate and late adverse effects. Although glucocorticoids are used for the management of these adverse effects, there is little evidence regarding the effectiveness of prophylactic glucocorticoids to prevent these complications. This trial will evaluate the efficacy of a short course of prophylactic glucocorticoids in the prevention of adverse effects of RAI treatment in patients with differentiated thyroid cancer.MethodsA phase II/III, single-centre, randomized, double-blinded, placebo-controlled, parallel-arm clinical trial will be conducted. Patients with differentiated thyroid cancer who are referred to RAI therapy at the National Cancer Institute, Sri Lanka, will be randomized into two arms consisting of 200 patients each. The experimental group will receive prophylactic oral prednisolone 0.5 mg/kg and omeprazole 20 mg single dose 6 h before RAI therapy followed by oral prednisolone 0.5 mg/kg and omeprazole 20 mg daily for 3 days. The control group will receive oral placebo and omeprazole 20 mg single dose 6 h before RAI therapy followed by oral placebo and omeprazole 20 mg daily for 3 days. Clinically significant adverse effects assessed as related to RAI as well as prednisolone therapy and the quality of life parameters will be compared between the two groups.DiscussionIf proven beneficial, this intervention can be incorporated into the standard practice to reduce early and intermediate adverse effects of RAI for thyroid cancer with a potential improvement of quality of life.Trial registrationSri Lanka Clinical Trials Registry SLCTR/2020/009. Registered prospectively on 23 February 2020. Items of the WHO Trial Registration Data Set are provided in the supplementary file.
Highlights
Radioactive iodine (RAI) therapy is the standard adjuvant treatment for differentiated thyroid cancer
The treatment of adverse effects of RAI is mainly symptomatic. This includes proper hydration, use of sialagogues, antiemetics and proton pump inhibitors, and in cases of inflammatory tumour expansion, glucocorticoids may be administered [5, 6]. This is the first randomized control clinical trial designed to assess the effectiveness of prophylactic steroids in reducing the adverse effects of RAI
We hypothesize that a short course of prophylactic prednisolone would be beneficial in reducing the early and intermediate adverse effects of RAI
Summary
Radioactive iodine (RAI) therapy is the standard adjuvant treatment for differentiated thyroid cancer (i.e. papillary and follicular). Adverse effects (up to 10 days after treatment) include local side effects (transient neck pain and swelling), salivary related (acute sialadenitis and xerostomia), nasal related (abnormalities in smell, epistaxis) and gastrointestinal side effects (ageusia, nausea, vomiting, stomatitis and ulcers). Radioactive iodine therapy is generally administered with high doses of a radioactive isotope of iodine (iodine-131), and in certain occasions, several cycles of treatment may be needed for an adequate response, in cases of recurrent diseases or progressive iodine-avid metastatic diseases. Such instances substantially increase the possibility of adverse effects of RAI [4]
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