Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Carbamide Peroxide

Sorafenib

144 patients spread urea cream (urea 20%)

144 patients spread placebo cream (urea 0%)

Sorafenib 400mg (twice daily), Spread urea cream (urea 20%)

Urea Cream 20%

Sorafenib 400mg (twice daily), Spread placebo cream (urea 0%)

Placebos

Ji Hoon Kim, MD

Many investigators have studied for prevention and care of Hand-Foot Skin Reaction(HFSR), and urea cream is typical representative. Recent study was performed prevention effect of urea cream for Hand-Foot Skin Reaction(HFSR) on 871 Chinese. But the study did not designed as placebo-control group and it had big defect in double-blinded.

Therefore, it needs complementary study as double-blinded placebo-controlled trial and effect of urea cream on Korean patient group.

Sorafenib is multiple tyrosine kinase inhibitor. It blocks path that such as Raf-1, Vascular Endothelial Growth Factor Receptor (VEGFR), Platelet-Drived Growth Factor Receptor-β (PDGFR-β), c-Jit, Flt-3. Sorafenib was known to increase life rate about processed hepatocellular carcinoma. So it is advised as standard treatment for liver cancer patient who has processed Barcelona Clinic Liver Cancer (BCLC) disease period C.

Sorafenib related side effect has reported such as fatigue, diarrhea, vomit, nausea, pruritus, depilation, Hand-Foot Skin Reaction(HFSR). Among the symptoms, Hand-Foot Skin Reaction(HFSR) is the most occurrence after using sorafenib and major reason of drug dose de-escalation, it function as decrease anti-cancer effect of sorafenib. It is known for the reason of Hand-Foot Skin Reaction(HFSR) occurrence is caused by tyrosine kinase inhibitive action, and its characteristic symptom is known as keratocyte necrosis, dermal edema, parakeratosis, hyperkeratosis. The level is categorized grade 1,2,3 according to the severity.

The result of meta-analysis of 24 clinical trials that contained 6000 patients, Hand-Foot Skin Reaction(HFSR) occured 39% of sorafenib used patients and 9% of total patients had grade 3 Hand-Foot Skin Reaction(HFSR). But prevalence rate on hepatocellular carcinoma patients who used sorafenib is about 51% on Japanese, 45% on Asia-pacific patient (inclusive Korean) and 73.6% on Chinese. Prevalence rate of Hand-Foot Skin Reaction(HFSR) is different from result of each study, but about 50% of sorafenib used patients has had Hand-Foot Skin Reaction(HFSR) generally and Asian has more higher degree of prevalence rate. Therefore, prevent and care of Hand-Foot Skin Reaction(HFSR) on Korean hepatocellular carcinoma patients who used sorafenib is required.

Urea cream is typical representative for prevention and care of Hand-Foot Skin Reaction(HFSR). As stability-guaranteed drug, it is relatively cheap, locally affect and has used for psoriasis treatment. Also it is known for curative effacement on Hand-Foot Skin Reaction(HFSR) after use tyrosine kinase inhibitor such as sorafenib, sunitinib.

Therefore, it needs complementary study as double-blinded placebo-controlled trial and effect of urea cream on Korean patient group.

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction

The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction in Patients With Korean Hepatocellular Carcinoma Patients: Multicenter, Prospective Randomized Double-Blind Controlled Study

Comparison of cumulative incidence of HFSR between placebo group and urea cream group

Comparison of cumulative incidence of severe HFSR (grade 2 or grade 3) between placebo group and urea cream group

Comparison of incidence of dose reduction or discontinuation of sorafenib due to HFSR on each group

Assessment of QOL related to HFSR using The Hand-Foot Skin Reaction and Quality of Life Questionnaire (HF-QoL) scoring system. HF-QOL instrument comprises a 20-item symptom scale and an 18-item daily activity scale. Each item was scored from 0 (not at all) to 4 (always or extremely). Therefore, the range of score for HF-QoL was from 0 to 152 points. (Ref. Anderson et al. The Oncoligist 2015;20:831-838)

The occurrence rate of other side effect excluding HFSR

Comparison of incidence of HFSR on 2, 4, 8, and 12 weeks between placebo group and urea cream group

Hanmi Pharmaceutical Company Limited

Korea University Guro Hospital

Associate professor

Skin and Connective Tissue Diseases

Wounds and Injuries

Breast Neoplasms

Head and Neck Neoplasms

Radiodermatitis

Dermatitis

Skin Diseases

Radiation Injuries

Pharmaceutical Solutions

Herbal and Botanical

Chamomile

Experimental Group 01: usual care + topical application of the gel recutita chamomile. Such intervention will be characterized by topical application of the gel C. recutita, concomitantly to the initiation of radiotherapy, should be applied on the irradiated three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).

Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the area irradiated three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).

The usual care consists of nursing consultation with instructional material (Manual guidelines) that is already done systematically in service. This query is made with all patients starting radiotherapy. Here, guidelines are provided about skin care and hydration, using topical moisturizing soap solution over the bath. Such information is contained in the manual that is provided to the patient during the consultation.

Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).

Chamomilla recutita gel

Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).

Urea cream

Elaine Barros Ferreira, RN

Paula Elaine Diniz dos Reis, RN, PhD

Marcia A Ciol, PhD

It aims to evaluate the efficacy of the chamomile recutita gel and urea cream in the prevention of radiodermatitis in patients with breast cancer or head and neck cancer undergoing radiotherapy.

Prophylactic Trial will consist of a control group and two experimental groups, namely control group (usual care), Experimental Group 01 (usual care + topical application of the gel C. recutita) and Experimental Group 02 (usual care + topical application of Urea based cream).

The doses used in the different compounds are being in test since february 2014 by a dose-response curve study, using 6 groups with three doses of urea cream and three doses of C. recutita gel.

The study will be conducted at the Center for High Complexity Oncology at University Hospital of Brasília (CACON/HUB), Brazil. The degree of radiodermatitis is evaluated weekly, according to established criteria to classify the effects of radiotherapy, which identifies grades 0, 1, 2 , 3 and 4, according to the score of the Radiation Therapy Oncology Group - RTOG. To evaluate the skin reaction will also be applied scale Common Terminology Criteria for Adverse Events (CTCAE) and Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

It is considered that patients undergoing radiotherapy in use gel based on C. recutita or use of cream based urea three times a day, concomitant radiotherapy, would present the following hypotheses:

* Null: equal incidence and severity of radiodermatitis when compared to the control group (usual care);
* Alternative 1: low incidence and severity of radiodermatitis when compared to patients who comprised the control group (usual care).
* Alternative 2: lower incidence and severity of radiodermatitis between the experimental groups (urea and chamomile).

Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

Prophylactic Interventions in the Management of Radiodermatitis in Patients With Breast or Head and Neck Cancer: a Randomized Clinical Trial

Time of occurrence of radiodermatitis second dose of radiation (or its absence during radiotherapy).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction	NCT03212625	Hepatocellular ...	Urea Cream 20% Placebos	-	Korea University Guro Hospital
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction	NCT03212625	Hepatocellular ...	Urea Cream 20% Placebos	-	Korea University Guro Hospital
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer	NCT02247830	Radiodermatitis	Chamomilla recu... Urea cream	18 Years -	University of Brasilia
Management Radiodermatitis in Patients With Breast or Head and Neck Cancer	NCT02247830	Radiodermatitis	Chamomilla recu... Urea cream	18 Years -	University of Brasilia
The Effect of Urea Cream on Sorafenib-associated Hand-Foot Skin Reaction	NCT03212625	Hepatocellular ...	Urea Cream 20% Placebos	-	Korea University Guro Hospital

Spots Global Cancer Trial Database for urea cream

Every month we try and update this database with for urea cream cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for urea cream

Every month we try and update this database with for urea cream cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for urea cream cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.