Evaluation of adverse events associated with immune checkpoint inhibitors in patients with head and neck cancer using a smartphone application (Fukusuppo App)
Not Applicable
- Conditions
- Patients with head and neck cancer who are scheduled to be treated with ICIs are eligible
- Registration Number
- JPRN-UMIN000050332
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method severe adverse event (AE) rate defined as grade 3 or higher AEs in CTCAE ver. 5.0 or AEs requiring emergency hospitalization
- Secondary Outcome Measures
Name Time Method 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