Evaluation of the protective effects of nanocurcumin against iodine therapy's side effects in thyroid cancer patients: a randomized, double-blind, placebo-controlled clinical trial
Objective: To study the protective effect of curcumin against the side effects of radioiodine therapy in patients with thyroid cancer
Type of study: randomized, double-blind, placebo-controlled clinical trial population groups: patients with newly diagnosed thyroid cancer who are candidate for radiotherapy.
Method: pateints will randomly divided in three groups, in group one patients will take 80 mg nano curcumin twice a day, starting From one week before until three weeks after radioiodine therapy. Group two takes 40 mg nano curcumine with the same structure, and group three takes placebo as follow.
The consequences of the study: the incidence and severity of oral mucositis and dysgenesia,In week one and three after iodine therapy and also reduction of the activity of the salivary glands and the success rates of Iodine-131 treatment after one year of treatment. The nausea during the first week after radioiodine therapy, Compared counts of the white blood cells and platelet three weeks, two months and one year after treatment between drugs and placebo groups, The prevalence of patient complaints after iodine therapy, The Plasma levels of curcumin and also ALT and AST variation, two and four weeks after taking the drug.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030917006N2
Registration date:2016-12-09, 1395/09/19
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Narjess Khatoun Ayati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2782
Email address
ayatin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences. (Primary sponsor)
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the protective effects of nanocurcumin against iodine therapy's side effects in thyroid cancer patients: a randomized, double-blind, placebo-controlled clinical trial
Public title
The protective effects of nanocurcumin against unpleasant effects of radiotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 65; patients with papillary or follicular thyroid cancer; Desire to join to study
Exclusion criteria: previous history of radioiodine therapy; history of head and neck radiotherapy; previous history of thyroid surgery; pregnancy; lactation; history of chronic rheumatologic disease; history of LASIK or PRK on eye or surgery of salivary glands; PT less than normal
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences