Hepatocellular CarcinomaPhase 2NCT01934829
Urea Cream Treatment Sorafenib-Associated HSFR in HCC
A Phase 2 study testing urea-based cream in people with Hepatocellular Carcinoma, run by Chinese Anti-Cancer Association at 11 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- urea-based cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 871 participants
- Where
- 11 sitesChina
- Study dates
- Jul 2009to Jul 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
301 Military Hospital, Beijing, China
Beijing, Beijing Municipality, 100039
302 Military Hospital, Beijing, China
Beijing, Beijing Municipality, 100039
Jilin Provincial Tumor Hospital, Jilin, China
Changchun, Jilin, 130012
Union Hospital of Fujian Medical University, Fujian, China
Fuzhou, Fujian, 350001
Guangdong Provincial People's Hospital, Guangdong, China
Guangzhou, Guangdong, 510080
The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
Guangzhou, Guangdong, 510630
Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
Haerbin, Heilongjiang, 150081
The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
Nanjing, Jiangsu, 210002
Zhongshan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, 200032
Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
Shanghai, Shanghai Municipality, 200438
Tianjin Cancer Hospital, Tianjin, China
Tianjin, Tianjin Municipality, 300060
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- urea-based cream
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urea-based creamDrug
Also called Nexavar is the brand name of sorafenib
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.
| Study group | Role | What they receive |
|---|---|---|
| urea-based cream | Experimental | 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 Receives: Drug: urea-based cream |
| best supportive care | Placebo comparator | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of all-grade HFSR
Measured: Starting sorafenib treatment within 12 weeks
Prophylactic topical application of ointment to reduce the hand-foot skin reactions in patients with hepatocellular carcinoma treated with sorafenib
Measured: Starting sorafenib treatment within 12 weeks
Secondary outcomes (3)
The percentage of patients requiring sorafenib dose-reduction
Measured: Starting sorafenib treatment within 12 weeks
The percentage of patients requiring discontinuation of sorafenib therapy
Measured: starting sorafenib treatment within 12 weeks
The percentage of patients discontinuing treatment
Measured: starting sorafenib treatment within 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Anti-Cancer Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Long Ye, PHD, Principal investigator, Zhongshan Hospital, Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934829
- Sponsor's protocol ID
- 1163
- Status last verified
- Aug 2013
- First submitted
- 30 Aug 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bosch FX, Ribes J, Cleries R, Diaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005 May;9(2):191-211, v. doi: 10.1016/j.cld.2004.12.009.
PubMed 15831268Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
PubMed 11668491Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
PubMed 14667750Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Shau WY, Chen DS. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group. N Engl J Med. 1997 Jun 26;336(26):1855-9. doi: 10.1056/NEJM199706263362602.
PubMed 9197213Young JL Jr, Ries LG, Silverberg E, Horm JW, Miller RW. Cancer incidence, survival, and mortality for children younger than age 15 years. Cancer. 1986 Jul 15;58(2 Suppl):598-602. doi: 10.1002/1097-0142(19860715)58:2+3.0.co;2-c.
PubMed 3719551
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01934829
- Acronym / sponsor ID
- 1163
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- Chinese Anti-Cancer AssociationUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urea-based cream | Experimental | Drug: urea-based creamAdvanced 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 |
| best supportive care | Placebo comparator | –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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urea-based creamAlso: Nexavar is the brand name of sorafeniburea-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. | Drug | urea-based cream |
Primary outcome
The incidence of all-grade HFSR
Time frame: Starting sorafenib treatment within 12 weeks
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
3 secondary outcomes
The percentage of patients requiring sorafenib dose-reduction
Time frame: Starting sorafenib treatment within 12 weeks
The percentage of patients requiring discontinuation of sorafenib therapy
Time frame: starting sorafenib treatment within 12 weeks
The percentage of patients discontinuing treatment
Time frame: starting sorafenib treatment within 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Results publication: PubMed 15831268Bosch FX, Ribes J, Cleries R, Diaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005 May;9(2):191-211, v. doi: 10.1016/j.cld.2004.12.009.
- Results publication: PubMed 11668491Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
- Results publication: PubMed 14667750Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
- Results publication: PubMed 9197213Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Shau WY, Chen DS. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group. N Engl J Med. 1997 Jun 26;336(26):1855-9. doi: 10.1056/NEJM199706263362602.
- Results publication: PubMed 3719551Young JL Jr, Ries LG, Silverberg E, Horm JW, Miller RW. Cancer incidence, survival, and mortality for children younger than age 15 years. Cancer. 1986 Jul 15;58(2 Suppl):598-602. doi: 10.1002/1097-0142(19860715)58:2+3.0.co;2-c.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheng-Long Ye, PHD principal investigator
Zhongshan Hospital, Fudan University, Shanghai, China
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing urea-based cream in people with Hepatocellular Carcinoma, run by Chinese Anti-Cancer Association at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of all-grade HFSR (time frame: Starting sorafenib treatment within 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01934829, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.