UMIN-CTR Clinical Trial

Basic information
Public title	Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
Acronym	Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
Scientific Title	Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
Scientific Title:Acronym	Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
Region	Asia(except Japan)

Condition
Condition	Head and neck cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To find out the clinical efficacy of iodine solution for prophylaxis of concurrent chemoradiation induced oral mucositis in head and neck cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Oral Mucositis Assessment Scale
Key secondary outcomes	- Pain score - Impact on swallowing score - Incidence, severity, onset, & duration of oral mucositis - Analgesic drug use - Total treatment break - Secondary infection of oral mucosa.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	- Iodine solution (Intervention) - Gargle 30 ml for 30 seconds - 3 times a day after meal - From the first day of concurrent chemoradiation to the day of completion
Interventions/Control_2	- Normal saline solution (Control) - Gargle 30 ml for 30 seconds - 3 times a day after meal - From the first day of concurrent chemoradiation to the day of completion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients should be diagnosed with head and neck cancer without distant metastasis. 2) Patients should be between 18 -70 years old of age. 3) Patient should be receiving concurrent chemotherapy with a platinum-based agent. 4) Oral mucosa should be included in the radiation field. 5) The planned radiation dose to the primary tumor should exceed 50 Gy.
Key exclusion criteria	1) Patients with an Eastern Cooperative Oncology Group Performance Score more than 2. 2) Patients with an allergy to iodine and/or seafood. 3) Patients who were unable to take part in the follow up schedule. 4) Patients who were pregnant or lactating. 5) Patients who had undergone prior radiation therapy. 6) Patients who were diagnosed with more than one primary cancer. 7) Patients who were diagnosed with hematologic malignancies. 8) Patients who were to undergo radiation therapy with altered fractionation. 9) Patients who were previously treated with hyperbaric oxygen therapy.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name YOTDANAI Middle name Last name NAMUANGCHAN
Organization	Khon Kaen University
Division name	Division of Radiation Oncology, Department of Radiology, Faculty of Medicine
Zip code	40002
Address	123 Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, THAILAND
TEL	+66-83-673-6731
Email	yotdna@kku.ac.th

Public contact
Name of contact person	1st name YOTDANAI Middle name Last name NAMUANGCHAN
Organization	Khon Kaen University
Division name	Division of Radiation Oncology, Department of Radiology, Faculty of Medicine
Zip code	40002
Address	123 Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, THAILAND
TEL	+66-83-673-6731
Homepage URL
Email	yotdna@kku.ac.th

Sponsor
Institute	Faculty of Medicine, Khon Kaen University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Khon Kaen University
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	THAI

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Ethics in Human Research, Khon Kaen University
Address	Room 5317, 3rd Floor Wadwichakarn Building, Faculty of Medicine, Khon Kaen University, Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, 40002, THAILAND
Tel	+66-89-714-1913
Email	eckku@kku.ac.th

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Srinagarind Hospital (Khon Kaen, THAILAND)

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 06 Day

Related information
URL releasing protocol	https://drive.google.com/open?id=1RuwgCmxwKpKBn__Kcv1UXiUeQHQujZEe&authuser=yotdna%40kku.ac.th&usp=d
Publication of results	Unpublished

Result
URL related to results and publications	https://drive.google.com/open?id=1WPtRZk34j3kLMQSRVmy30tbOqtqs6Epy&authuser=yotdna%40kku.ac.th&usp=d
Number of participants that the trial has enrolled	20
Results	As in attached URL above
Results date posted	2021 Year 01 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Participants in this study consisted of twelve men and eight women, with mean ages of 53.90 & 56.30 years in the treatment & control groups respectively. Primary cancer sites were; oral cavity (30%), oropharynx (30%), nasopharynx (30%) and nasal cavity (10%). Most of the patients had locally advanced disease; Stage III (35%) and Stage IV (50%). These were assigned to definitive treatment (80%), while the rest were post-operative (20%). Radiation techniques were 3D-CRT (50%) and IMRT/VMAT (50%). The most common concurrent chemotherapy regimen was weekly cisplatin (55%). The median radiation dose was 70 Gy in both groups. The mean oral cavity doses were 59.30 & 49.72 Gy, the mean radiation volumes were 1269.99 & 1404.59 cm3 and the mean durations of treatment were 64.40 & 57.80 days, in the treatment & control groups respectively. Note that the mean oral cavity dose was about 10 Gy higher in the iodine solution group. There is no statistically significant difference in characteristic data between the two groups.
Participant flow	After obtaining informed consent, the patients were randomly assigned to the treatment or control group, by stratified simple random sampling with primary cancer site (Oral cavity vs Oropharynx vs Nasopharynx vs Nasal cavity), and stage groups (I vs II vs III vs IV). Opaque envelopes containing a card marked with the letter A or B were then picked by the patients, assigning themselves to either the treatment or control group.
Adverse events	The reported mouthwashes' adverse effects were nausea & unfavorable taste/odor.
Outcome measures	An oral examination was done before the start of CCRT, at weekly intervals during CCRT, at the end of CCRT, and 4 weeks after completion of CCRT, using the Oral Mucositis Assessment Scale (OMAS) and World Health Organization (WHO) criteria for grading of oral mucositis.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 10 Day
Date of IRB	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 03 Month 20 Day
Last follow-up date	2019 Year 12 Month 25 Day
Date of closure to data entry	2020 Year 01 Month 25 Day
Date trial data considered complete	2020 Year 02 Month 20 Day
Date analysis concluded	2020 Year 03 Month 18 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 06 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048998