UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042920 |
|---|---|
| Receipt number | 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 00:02:14 |
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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
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
yotdna@kku.ac.th
Sponsor or person
Institute
Faculty of Medicine, Khon Kaen University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048998
