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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042920
受付番号 R000048998
科学的試験名
一般公開日(本登録希望日) 2021/01/06
最終更新日 2021/01/06

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
一般向け試験名略称/Acronym
Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
科学的試験名/Scientific Title
Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
科学的試験名略称/Scientific Title:Acronym
Prophylaxis of oral mucositis with iodine solution in head & neck cancer patients during chemoradiation, a randomized controlled trial.
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Head and neck cancer
疾患区分1/Classification by specialty
血液・腫瘍内科学/Hematology and clinical oncology
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/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
目的2/Basic objectives2 有効性/Efficacy
目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1 探索的/Exploratory
試験の性質2/Trial characteristics_2 実務的/Pragmatic
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Oral Mucositis Assessment Scale
副次アウトカム評価項目/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.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design 並行群間比較/Parallel
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 二重盲検/Double blind -all involved are blinded
コントロール/Control プラセボ・シャム対照/Placebo
層別化/Stratification はい/YES
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 施設を考慮していない/Institution is not considered as adjustment factor.
ブロック化/Blocking はい/YES
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
医薬品/Medicine
介入1/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
介入2/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
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old より上/<
年齢(上限)/Age-upper limit
70 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/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.
除外基準/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.
目標参加者数/Target sample size 50

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

YOTDANAI
ミドルネーム
NAMUANGCHAN
所属組織/Organization
Khon Kaen University
所属部署/Division name
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine
郵便番号/Zip code 40002
住所/Address
123 Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, THAILAND
電話/TEL +66-83-673-6731
Email/Email yotdna@kku.ac.th

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

YOTDANAI
ミドルネーム
NAMUANGCHAN
組織名/Organization
Khon Kaen University
部署名/Division name
Division of Radiation Oncology, Department of Radiology, Faculty of Medicine
郵便番号/Zip code 40002
住所/Address
123 Mittraphap road, Nai Muang Subdistrict, Muang District, Khon Kaen, THAILAND
電話/TEL +66-83-673-6731
試験のホームページURL/Homepage URL
Email/Email yotdna@kku.ac.th

実施責任組織/Sponsor
機関名/Institute その他 Faculty of Medicine, Khon Kaen University
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Faculty of Medicine, Khon Kaen University
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization その他の国の官庁/Government offices of other countries
研究費拠出国/Nationality of Funding Organization
THAI

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


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

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions Srinagarind Hospital (Khon Kaen, THAILAND)

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2021 01 06

関連情報/Related information
プロトコル掲載URL/URL releasing protocol https://drive.google.com/open?id=1RuwgCmxwKpKBn__Kcv1UXiUeQHQujZEe&authuser=yotdna%40kku.ac.th&usp=d
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications https://drive.google.com/open?id=1WPtRZk34j3kLMQSRVmy30tbOqtqs6Epy&authuser=yotdna%40kku.ac.th&usp=d
組み入れ参加者数/Number of participants that the trial has enrolled 20
主な結果/Results
As in attached URL above
主な結果入力日/Results date posted
2021 01 05
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/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.
参加者の流れ/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.
有害事象/Adverse events
The reported mouthwashes' adverse effects were nausea & unfavorable taste/odor.
評価項目/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.
個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 試験終了/Completed
プロトコル確定日/Date of protocol fixation
2019 01 10
倫理委員会による承認日/Date of IRB
2019 01 28
登録・組入れ開始(予定)日/Anticipated trial start date
2019 03 20
フォロー終了(予定)日/Last follow-up date
2019 12 25
入力終了(予定)日/Date of closure to data entry
2020 01 25
データ固定(予定)日/Date trial data considered complete
2020 02 20
解析終了(予定)日/Date analysis concluded
2020 03 18

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2021 01 06
最終更新日/Last modified on
2021 01 06


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000048998
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048998

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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