UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060574 |
|---|---|
| Receipt number | R000069121 |
| Scientific Title | Assessment of Fatigue in Head and Neck Cancer Patients Treated with Cisplatin-Based Concurrent Chemoradiotherapy: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/04 09:35:41 |
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Basic information
Public title
Assessment of Fatigue in Head and Neck Cancer Patients Treated with Cisplatin-Based Concurrent Chemoradiotherapy: A Prospective Observational Study
Acronym
Fatigue trial
Scientific Title
Assessment of Fatigue in Head and Neck Cancer Patients Treated with Cisplatin-Based Concurrent Chemoradiotherapy: A Prospective Observational Study
Scientific Title:Acronym
Fatigue trial
Region
| Japan |
Condition
Condition
Patients with head and neck cancer who received cisplatin-based concurrent chemoradiotherapy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the actual status of fatigue after cisplatin-based concurrent chemoradiotherapy in patients with head and neck cancer
Basic objectives2
Others
Basic objectives -Others
QOL analysis based on questionnaire surveys
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Fatigue was assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale
Key secondary outcomes
Comprehensive quality-of-life assessment using the EORTC QLQ-C30
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
i) Histological or cytological confirmation of head and neck cancer.
ii) Scheduled to complete cisplatin-based concurrent chemoradiotherapy.
iii) Able to understand written Japanese.
iv) Provided written informed consent after receiving a full explanation of the study.
Key exclusion criteria
i) Planned to receive subsequent treatment after chemoradiotherapy for head and neck cancer.
ii) Treated with radiotherapy alone (without concurrent chemotherapy).
iii) Deemed inappropriate for participation in this study by the attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo Medical University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
160-0023
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
hidekich@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo Medical University
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
160-0023
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
hidekich@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
irb@tokyo-med.ac.jp> <irb@tokyo-med.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to assess fatigue and quality of life in patients after completion of cisplatin-based chemoradiotherapy using periodic questionnaire surveys. Written informed consent will be obtained from patients scheduled to complete treatment. The first questionnaire will be collected within 5 days after radiotherapy, and the final questionnaire will be administered 6 months after consent.
Management information
Registered date
| 2026 | Year | 02 | Month | 04 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069121
