Determination of the preventing and therapeutic effect of curcumin in radiotherapy-induced mucositis of head and neck cancers
Design
A randomized, double-blinded, clinical trial(phase III) for 40 patients has been designed. Seal envelope will be used to randomize. Randomization is performed using a computer-generated random number table.
Settings and conduct
This double-blind randomized clinical trial is conducted at Mashhad Dental School, Iran. Since the apparent appearance of the drugs is not the same, curcumin and placebo are prepared and coded by the clinical pharmacologist in the same pharmaceutical package and code decoding takes place during statistical analysis. Participants and care providers and assessing outcomes and the statistician are blinded to the type of drug because drugs are placed in similar seal envelope packs.
Participants/Inclusion and exclusion criteria
Inclusion criteria were the following: minimum age of 18 years, presence of head and neck cancer, radiation therapy of 50 Gy or greater, at least 50% of patient’s oral cavity in the field of radiation, and willing to be a part of the study and sign the informed consent.
Exclusion criteria were the following: the history of previous radiation therapy or chemotherapy, chemotherapy protocol in addition to radiotherapy, any allergy to condiments, especially “Turmeric root”, having a pre-existing oral disease such as an active oral infection or an oral ulceration.
Intervention groups
The study group: 80 mg/d oral curcumin (1 capsule of SinaCurcumin® 80 per day), during radiotherapy.
The control group: placebo tablets (containing lactose) once daily, during radiotherapy.
Main outcome variables
Severity of mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039318N2
Registration date:2018-05-23, 1397/03/02
Registration timing:registered_while_recruiting
Last update:2018-05-23, 1397/03/02
Update count:0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Ala Ghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
ghazial@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-27, 1397/02/07
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the preventing and therapeutic effect of curcumin in radiotherapy-induced mucositis of head and neck cancers
Public title
Assessing the preventing and therapeutic effect of curcumin mucositis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria were the following: minimum age of 18 years, presence of head and neck cancer, radiationtherapy of 50 Gy or greater, at least 50% of patient’s oral cavity in the field of radiation, and willing to be a part of the study and sign the informed consent..
Exclusion criteria:
Exclusion criteria were the following: the history of previous radiation therapy or chemotherapy, chemotherapy protocol in addition to radiotherapy, any allergy to condiments, especially “Turmeric root”, having a pre-existing oral disease such as an active oral infection or an oral ulceration.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups, namely the Study and Control groups. Randomization is performed using a computer-generated random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, since the apparent appearance of the drugs is not the same, curcumin and placebo are prepared and coded by the clinical pharmacologist in the same pharmaceutical package and code decoding takes place during statistical analysis.The prepared medicine packs are the same for the two group. Packages are randomly delivered to patients. The participants and care providers and assessing outcomes and the statistician are blinded to type of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشگاه علوم پزشکی مشهد- کمیته دانشکده ای اخلاق در پژوهشهای انسانی
Before the initiation of radiotherapy and then on days 7, 14, 21, 28, 35 and 42 of the radiotherapy course
Method of measurement
the National Cancer Institute Common Toxicity Criteria version 2 scale (NCI CTC v.2)
Secondary outcomes
1
Description
The effect of curcumin on the onset of mucositis
Timepoint
Before the initiation of radiotherapy and then on days 7, 14, 21, 28, 35 and 42 of the radiotherapy course
Method of measurement
the National Cancer Institute Common Toxicity Criteria version 2 scale (NCI CTC v.2)
Intervention groups
1
Description
Intervention group:80 mg/d oral curcumin (1 capsule of SinaCurcumin® 80 per day), during radiotherapy (6 weeks). Each soft gel of SinaCurcumin® contains 80 mg of curcumin in the form of nano-micelle.
Category
Treatment - Drugs
2
Description
Control group: placebo tablets (containing lactose) once daily during radiotheraoy. prepared by a pharmacologist colleague
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial Diseases Department of Mashhad Dental School