UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041738 |
|---|---|
| Receipt number | R000047642 |
| Scientific Title | Prospective observational study on taste dysfunction and quality of life in head and neck cancer patients treated with intensity-modulated radiotherapy |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2025/03/13 10:37:17 |
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Basic information
Public title
Prospective observational study on taste dysfunction and quality of life
in head and neck cancer patients treated with intensity-modulated radiotherapy
Acronym
Taste dysfunction and quality of life after head and neck IMRT
Scientific Title
Prospective observational study on taste dysfunction and quality of life
in head and neck cancer patients treated with intensity-modulated radiotherapy
Scientific Title:Acronym
Taste dysfunction and quality of life after head and neck IMRT
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess subjective and objective taste dysfunction in head and neck cancer patients treated with IMRT
Basic objectives2
Others
Basic objectives -Others
To assess the effects of taste dysfunction on quality of life in head and neck cancer patients treated with IMRT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste dysfunction at 1,3,6 and 12 months after the end of radiation
Key secondary outcomes
QOL score at 1,3,6 and 12 months after the end of radiation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histopathologically confirmed head and neck cancer
2. Treated with definitive IMRT at our institution
3. Aged 20 or older
4. ECOG performance status:0-2
5. Written informed consent provided by the patient
Key exclusion criteria
1. Prior history of head and neck cancer receiving radiation
2. Prior history of surgery for oral cavity, pharynx and larynx
3. Previously diagnosed taste dysfuncion
4. Difficulty in oral intake
5. Difficulty in writing questionnaire
6. Any condition that is unstable as judged by the investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Nakajima |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology
Zip code
606-8507
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City, Kyoto
TEL
0757513762
anakajim@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Nakajima |
Organization
Kyoto University Hospital
Division name
Department of Radiation Oncology
Zip code
606-8507
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City, Kyoto
TEL
0757513762
Homepage URL
anakajim@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education,Culture,Sports,Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 22 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 22 | Day |
Other
Other related information
In this observational study, taste dysfunction, saliva production and quality of life are assessed at baseline, 1 month, 3month, 6 months and 12 months after irradiation. Taste dysfunction is assessed using the whole-mouth taste method. Patient QOL is measured with QOL questionnaire(EORTC QLQ-C30 and EORTC QLQ-H&N35).
Management information
Registered date
| 2020 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047642
