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

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 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

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

Value
https://center6.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