UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050332 |
|---|---|
| Receipt number | R000057310 |
| Scientific Title | Effectiveness of smartphone application "Fukusuppo App" to support head and neck cancer patients in the management of toxicities associated with immnue checkpoint inhibitor: a prospective observation study |
| Date of disclosure of the study information | 2023/03/06 |
| Last modified on | 2025/02/16 11:39:48 |
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Basic information
Public title
Evaluation of adverse events associated with immune checkpoint inhibitors in patients with head and neck cancer using a smartphone application (Fukusuppo App)
Acronym
Fukusuppo study
Scientific Title
Effectiveness of smartphone application "Fukusuppo App" to support head and neck cancer patients in the management of toxicities associated with immnue checkpoint inhibitor: a prospective observation study
Scientific Title:Acronym
Fukusuppo study
Region
| Japan |
Condition
Condition
Patients with head and neck cancer who are scheduled to be treated with ICIs are eligible
Classification by specialty
| Medicine in general | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Using a smartphone application, "FukuSuppo App", we aim to quickly and accurately identify immune-related adverse events associated with immune checkpoint inhibitors in head and neck cancer patients, and to investigate the possibility of preventing or avoiding severe adverse events by early therapeutic intervention for these adverse events.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
severe adverse event (AE) rate defined as grade 3 or higher AEs in CTCAE ver. 5.0 or AEs requiring emergency hospitalization
Key secondary outcomes
Overall survival, progression free survival, progression free survival 2, Time from onset of adverse event to start of treatment, time to treatment failure, treatment discontinuation rate due to AE, rate of patients who have received subsequent therapy, time to next treatment, quality of life
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically and cytologically confirmed to be a malignant tumor.
2) The primary site of tumor is larynx, oropharynx, hypopharynx, nasopharynx, oral cavity, nasal sinus, or salivary gland.
3) The patient is planned to be treated with either pembrolizumab or nivolumab monotherapy.
4) The patient can read Japanese.
5) Have a smartphone (both iOS and Android) from which applications can be downloaded.
6) The patient has been fully informed and has given his/her written consent.
Key exclusion criteria
1) The primary site of tumor is thyroid.
2) Patient has a history of immune checkpoint inhibitors including other types of cancer.
3) Patient is planned to be treated with both immune checkpoint inhibitors and chemotherapy.
4) The patient's physician determines that the patient is not suitable to participate in this study.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Tahara |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL
04-7133-1111
matahara@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Tanaka |
Organization
National Cancer Center Hospital East
Division name
Head and Neck Oncology
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
TEL
04-7133-1111
Homepage URL
hidetana@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University, Jikei University School of Medicine, Nagoya University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center East
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Tel
04-7133-1111
irst@ncc.go.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
国立がん研究センター東病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 06 | 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
| 2022 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective cohort study.
Patients who visited our hospital between 03/06/2023 and 08/31/2024 and met the inclusion criteria for selection will be included.
Patients answer a question form on the application once a day. The answered data is immediately updated and shared on the dedicated server of the "Fuku-suppo app," and the researcher checks it once a day. Treatment for adverse events should be carried out as usual, referring to the hospital's irAE handling manual.
Patient background, disease background, adverse events, and outcomes will be entered into the EDC and managed.
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057310
