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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041738
Receipt No. 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 2021/03/10

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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
Email 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
Email anakajim@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
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 Enrolling by invitation
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
2023 Year 10 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2021 Year 03 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047642

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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