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Completed

NCT Number: NCT01934829

Urea Cream Treatment Sorafenib-Associated HSFR in HCC

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

301 Military Hospital, Beijing, China, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

urea-based cream

Drug

urea-based cream (10% urea; Eucerin) 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for a maximum of 12 weeks .

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.

Other names: Nexavar is the brand name of sorafenib

Primary outcomes

  1. The incidence of all-grade HFSR

    Time frame: Starting sorafenib treatment within 12 weeks

  2. Prophylactic topical application of ointment to reduce the hand-foot skin reactions in patients with hepatocellular carcinoma treated with sorafenib

    Time frame: Starting sorafenib treatment within 12 weeks

Secondary outcomes

  1. The percentage of patients requiring sorafenib dose-reduction

    Time frame: Starting sorafenib treatment within 12 weeks

  2. The percentage of patients requiring discontinuation of sorafenib therapy

    Time frame: starting sorafenib treatment within 12 weeks

  3. The percentage of patients discontinuing treatment

    Time frame: starting sorafenib treatment within 12 weeks

Sponsors and collaborators

Lead sponsor

Chinese Anti-Cancer Association

Other

Registry information

Official study title

Randomized Controlled Phase II Study of the Prophylactic Effect of Urea-Based Cream on Sorafenib-Associated Hand-Foot Skin Reactions in Patients With Advanced Hepatocellular Carcinoma

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 4, 2013
Registry last updated
Sep 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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