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 2023/06/19 23:02:14

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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 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

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

No longer recruiting

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 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

2023 Year 06 Month 19 Day



Link to view the page

Value
https://center6.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