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Study protocol
Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single centre, phase II/III, randomized, double blinded, placebo controlled clinical trial
Umesh Jayarajah
National Hospital of Sri Lanka
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0398-5197
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background
Radioactive 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.
Methods
A 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 randomised into two arms consisting of 200 patients each. The experimental group will receive prophylactic oral prednisolone 0.5mg/kg and omeprazole 20mg single dose 6 hours before RAI therapy followed by oral prednisolone 0.5mg/kg and omeprazole 20mg daily for 3 days. The control group will receive oral placebo and omeprazole 20mg single dose 6 hours before RAI therapy followed by oral placebo and omeprazole 20mg 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.
Discussion
If 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 registration
Registration ID: Sri Lanka Clinical Trials Registry: SLCTR/2020/009 Registered prospectively on 23 February 2020. Url: https://slctr.lk/trials/slctr-2020-009
Keywords
prednisolone, adverse effects, radioactive iodine therapy, thyroid cancer, study protocol, randomised control trial
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CURRENT STATUS: Published
Version 1
Posted 13 May, 2020
Published
On 29 Sep, 2020
No community comments so far
Review #1 received
Received 19 Jul, 2020
Review #2 received
Received 09 Jul, 2020
Reviewer #2 agreed
On 06 Jul, 2020
Reviewers invited
Invitations sent on 03 Jul, 2020
Reviewer #1 agreed
On 03 Jul, 2020
Editor assigned
On 06 Jun, 2020
Submission checks complete
On 12 May, 2020
First submitted
On 02 Apr, 2020
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single centre, phase II/III, randomized, double blinded, placebo controlled clinical trial
Umesh Jayarajah
National Hospital of Sri Lanka
Corresponding Author
ORCiD: https://orcid.org/0000-0002-0398-5197
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 1
Posted 13 May, 2020
Published
On 29 Sep, 2020
No community comments so far
Review #1 received
Received 19 Jul, 2020
Review #2 received
Received 09 Jul, 2020
Reviewer #2 agreed
On 06 Jul, 2020
Reviewers invited
Invitations sent on 03 Jul, 2020
Reviewer #1 agreed
On 03 Jul, 2020
Editor assigned
On 06 Jun, 2020
Submission checks complete
On 12 May, 2020
First submitted
On 02 Apr, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background
Radioactive 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.
Methods
A 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 randomised into two arms consisting of 200 patients each. The experimental group will receive prophylactic oral prednisolone 0.5mg/kg and omeprazole 20mg single dose 6 hours before RAI therapy followed by oral prednisolone 0.5mg/kg and omeprazole 20mg daily for 3 days. The control group will receive oral placebo and omeprazole 20mg single dose 6 hours before RAI therapy followed by oral placebo and omeprazole 20mg 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.
Discussion
If 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 registration
Registration ID: Sri Lanka Clinical Trials Registry: SLCTR/2020/009 Registered prospectively on 23 February 2020. Url: https://slctr.lk/trials/slctr-2020-009
Figure 1