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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042920
Receipt No. R000048998
Scientific Title Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
Date of disclosure of the study information 2021/01/06
Last modified on 2021/01/06

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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