Evaluation of adverse events associated with immune checkpoint inhibitors in patients with head and neck cancer using a smartphone application (Fukusuppo App)

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 - Fukusuppo study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050332

Enrollment

Registered

2023-03-06

Start date

2023-03-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with head and neck cancer who are scheduled to be treated with ICIs are eligible

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
severe adverse event (AE) rate defined as grade 3 or higher AEs in CTCAE ver. 5.0 or AEs requiring emergency hospitalization	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactHideki Tanaka

National Cancer Center Hospital East Head and Neck Oncology

hidetana@east.ncc.go.jp04-7133-1111

Outcome results