Fruquintinib-induced hand-foot syndrome Hand Foot Syndrome(HFS)
Conditions
Interventions
Use of diclofenac sodium gel 1% as a preventive topical treatment for hand-foot syndrome induced by fruquintinib
Sponsors
Suzuki Nobumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with unresectable advanced or recurrent colorectal cancer who are refractory or intolerant to regimens including fluorouracil, oxaliplatin, irinotecan, FTD/TPI, or regorafenib (2)Patients who will use fruquintinib (3)Eastern Cooperative Oncology Group performance status of 0 or 1 (4)Age 18 years or older at the time of consent (5)Expected prognosis of at least 8 weeks at the time of enrollment (6)Gender: not specified (7)Patients who have received sufficient explanation about the study, fully understood it, and provided written informed consent of their own free will (8)Patients who are able to attend outpatient visits according to the study schedule
Exclusion criteria
Exclusion criteria: (1)Patients with aspirin induced asthma (asthma attacks triggered by NSAIDs) or a history of aspirin induced asthma (2)Patients with a history of hypersensitivity to diclofenac (3)Patients with Grade 2 or higher peripheral neuropathy (CTCAE) prior to the start of the study (4)Patients with diseases requiring continuous use of steroids or with dermatitis that makes it difficult to evaluate the efficacy of the study drug (5)Patients who plan to continuously take celecoxib, pyridoxine, or steroids during the study period (6)Patients with skin diseases on the palms or soles prior to the study, or with residual skin disorders caused by chemotherapy (7)Pregnant women or those unable to cooperate with appropriate contraception during the study period (8)Others deemed inappropriate for participation in the study by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 2 or higher hand-foot syndrome (CTCAE v5.0) within two months after the start of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Time to onset of Grade 2 or higher hand-foot syndrome (HFS) (2)Incidence of Grade 1 or higher HFS within two months after the start of chemotherapy (3)Time to onset of Grade 1 or higher HFS (4)Incidence of adverse events related to the study drug (5)Rate of dose reduction, interruption, or discontinuation of fruquintinib due to HFS (6)Average relative dose intensity of fruquintinib | — |
Contacts
Public ContactYu Miyakawa
The University of Tokyo Hospital
Outcome results
None listed