Urea Cream Treatment Sorafenib-Associated HSFR in HCC

Chinese Anti-Cancer Association

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: urea-based cream

Study type: Interventional

Funder types: Other

Identifiers

NCT01934829

1163

Details and patient eligibility

About

Although sorafenib is effective and safe in patients with advanced hepatocellular carcinoma (HCC), it increases dermatologic toxicities, including hand-foot skin reaction (HFSR), which may have a negative impact on patient quality of life (QoL). Urea-based creams may have a prophylactic effect on sorafenib-induced HFSR in HCC patients.

Full description

Mild hyperkeratosis is an early sign of HFSR and may sometimes be the only manifestation of sorafenib-associated HFSR. Urea is useful for the treatment of hyperkeratotic conditions and has been recommended for the treatment of multitargeted kinase inhibitor-related HFSR . To our knowledge, no randomized, controlled trials to date have evaluated treatments to prevent/palliate sorafenib-associated HFSR. We therefore tested the prophylactic effects of a urea-based cream on the incidence of HFSR associated with sorafenib treatment of patients with advanced HCC.

Enrollment: 871 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients with hepatocellular carcinoma will receive sorafenib per instructions of the package insert
• The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
• The patients must be willing and able to complete the biweekly visits for the first 3 months;
• The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients
• The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
• The patient's life expectancy is ≥3 months
• The patients must provide written informed consents

Exclusion criteria

• The patients participated in other clinical trials
• The patients received sorafenib therapy prior to enrollment
• The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
• The patient's sorafenib dosage exceeds 400mg, twice daily

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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871 participants in 2 patient groups, including a placebo group

urea-based cream

Experimental group

Description:

Advanced HCC throughout China were treated with 10% urea-based cream 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for up to 12 weeks

Treatment:

Drug: urea-based cream

best supportive care

Placebo Comparator group

Description:

BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator