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Prevention of Hand-foot Skin Reaction

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
best support care
moisture cream
10% urea-based cream
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring hand-foot skin reaction, side effect of sorafenib, symptom related to target therapy, efficacy of urea-based cream, symptom management

Eligibility Criteria

54 Years - 91 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HCC by proof of pathology
  • Presence of tumor thrombus in the main trunk of the portal vein or the first-order branches of the portal vein with minimal ascetics or with no ascetics by abdominal CT scan
  • Child-Pugh liver function class A
  • Planning to receive oral sorafenib 400 mg twice per day
  • Age of 20 or more years old
  • Able to communication in Chinese, Taiwanese or Hakka

Exclusion Criteria:

  • Encephalopathy, psychosis, cognition impairment, blindness or hearing impairment
  • Allergic history to urea
  • Present ulceration, blisters, infective problems on the palms or soles
  • Previous surgery, systematic chemotherapy or frequent radial ablation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Experimental

    Active Comparator

    Arm Label

    Best support care (BSC)

    BSC plus moisture cream

    10% urea-based cream

    Arm Description

    Interventions for comparison group (group C) who received BSC alone were (1) informed of potential presentations of HFSR, (2) asked for wearing waterproof gloves before execute household or work with water, (3) provided the method of contacting with healthcare specialists for confirming early diagnosis of HFSR, and (4) asked for self-report when they occurred symptoms of HFSR.

    The A group with BCS plus moisturizing cream received the interventions as the comparison group, was given the moisturizing cream (dimethicone, fragrance free, Aveeno, United States) for 9 times and was instructed how to use the cream. The education of usage included (1) using the cream twice a day from 3 days before starting sorafenib and each week post starting sorafenib, (2) scooping out nut-sized cream with a unique spoon each time, (3) gently applied the cream evenly on symmetrical palms below wrists and symmetrical soles below ankles each time, (4) wore unique cotton gloves immediately after the appalment of cream for 30 minutes each time.

    The B group with BCS plus 10% urea-based cream had the similar interventions as the A group with BCS plus moisturizing cream except being given the cream container with different component (10% urea; Sipharr, Taiwan). The outlook of the containers with the two kinds of cream was the same. All the cream looks white and grey.

    Outcomes

    Primary Outcome Measures

    Scale
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0

    Secondary Outcome Measures

    Scale
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Full Information

    First Posted
    August 29, 2020
    Last Updated
    September 23, 2020
    Sponsor
    Taipei Veterans General Hospital, Taiwan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04568330
    Brief Title
    Prevention of Hand-foot Skin Reaction
    Official Title
    Re-validating Prophylactic Efficacy of Urea-based Cream on Sorafenib-induced Hand-foot Skin Reaction in Patients With Advanced Hepatocellular Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    March 21, 2014 (Actual)
    Primary Completion Date
    November 11, 2015 (Actual)
    Study Completion Date
    December 11, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Veterans General Hospital, Taiwan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Sorafenib-induced hand-foot skin reaction (HFSR) is a dose-dependent side effect in patients with advance hepatocellular carcinoma (HCC). The appropriate prophylactic dose of urea-based cream and comparison of its effectiveness with other creams remain unclear. The aim of this study was re-validating the prophylactic HFSR incidence density and cutaneous wetness of 10% urea-based cream on sorafenib-induced HFSR in patients with advanced HCC.
    Detailed Description
    Methods Patients This study population consisted of patients with (1) HCC by proof of pathology, (2) presence of tumor thrombus in the main trunk of the portal vein or the first-order branches of the portal vein with minimal ascetics or with no ascetics by abdominal CT scan, (3) Child-Pugh liver function class A, (4) planning to receive oral sorafenib 400 mg twice per day, (5) age of 20 or more years old, and (6) able to communication in Chinese, Taiwanese or Hakka. Patients with (1) encephalopathy, psychosis, cognition impairment, blindness or hearing impairment, (2) allergic history to urea, (3) present ulceration, blisters, infective problems on the palms or soles, or (4) previous surgery, systematic chemotherapy or frequent radial ablation were excluded. Research procedure This is a randomized double-blind experiment study. Sample size was estimated by the G. power software version 3.1, which was set with logistic regression, odds ratio: 3.8, and power: 0.80. The estimated sample size should be 125 at least. This study, there was recruited 129 patients (43 patients in each groups). All eligible patients were recruited from Taipei Veterans General Hospital between January 1st and December 31th, 2014. They were randomly assigned in a ratio of 1:1:1 to treat with best supportive care plus moisturizing cream (A group), BSC plus 10% urea-based cream (B group) and BSC alone (group C which is comparison group),by method of EXCEL random sampling. A case manager recruited the eligible patients who also conducted informed consent and patient education. A research employee had responsibilities to record patients' demographic data, provide non-label cream and check previous container of the cream that should be exhausted. A medical oncologist or a nurse had responsibilities to assess patients' severity of HFSR and cutaneous wetness. The assessment was done on 3 days before starting sorafenib treatment and each 7 days after the starting, total 9 times. Creams were provided after the assessment. When patients developed HFSR, they will be referred to receive the most appropriate management. Interventions Interventions for group C (comparison group) who received BSC alone were (1) informed of potential presentations of HFSR, (2) asked for wearing waterproof gloves before execute household or work with water, (3) provided the method of contacting with healthcare specialists for confirming early diagnosis of HFSR, and (4) asked for self-report when they occurred symptoms of HFSR. The A group with BCS plus moisturizing cream received the interventions as the comparison group, was given the moisturizing cream (dimethicone, fragrance free, Aveeno, United States) for 9 times and was instructed how to use the cream. The education of usage included (1) using the cream twice a day from 3 days before starting sorafenib and each week post starting sorafenib, (2) scooping out nut-sized cream with a unique spoon each time, (3) gently applied the cream evenly on symmetrical palms below wrists and symmetrical soles below ankles each time, (4) wore unique cotton gloves immediately after the appalment of cream for 30 minutes each time. A B group with BCS plus 10% urea-based cream had the similar interventions as the A group with BCS plus moisturizing cream except being given the cream container with different component (10% urea; Sipharr, Taiwan). The outlook of the containers with the two kinds of cream was the same. All the cream looks white and grey. Outcomes and assessment Data of con founders and two end-points, incidence density of HFSR and cutaneous wetness, were collected. The con-founders included gender, age, numbers of chronic illnesses, numbers of metastatic regions as well as levels of white count, hemoglobin, bleeding time, liver enzymes, albumin and electrolyte. The grades of HFSR were assessed by NCI-CTCAE version 4, which was developed by Dueck et al. This is an available psychometric patient-reported instrument. Body water with 33% or less meant dry skin, 34% to 37% meant mild dry skin, 38% to 42% meant general status, 43% to 46/% was mild moisty skin and 47% or more presented moisty skin. When using the scanner, examiners had to confirm whether it tied to fix on the skin. Ethical considerations This study was approved by the Institution Review Board of the Taipei Veterans General Hospital (2013-13-009B). Informed consent was obtained from all patients by a case manager on 3 days before starting sorafenib. Patients were explained the study protocol and were educated self-care skills by the case manager. All of them were well aware that their rights will be protected, the risk of participation will be limited to the lowest and most suitable management will be arranged when they developed sorafenib-induced HFSR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma
    Keywords
    hand-foot skin reaction, side effect of sorafenib, symptom related to target therapy, efficacy of urea-based cream, symptom management

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    129 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Best support care (BSC)
    Arm Type
    Other
    Arm Description
    Interventions for comparison group (group C) who received BSC alone were (1) informed of potential presentations of HFSR, (2) asked for wearing waterproof gloves before execute household or work with water, (3) provided the method of contacting with healthcare specialists for confirming early diagnosis of HFSR, and (4) asked for self-report when they occurred symptoms of HFSR.
    Arm Title
    BSC plus moisture cream
    Arm Type
    Experimental
    Arm Description
    The A group with BCS plus moisturizing cream received the interventions as the comparison group, was given the moisturizing cream (dimethicone, fragrance free, Aveeno, United States) for 9 times and was instructed how to use the cream. The education of usage included (1) using the cream twice a day from 3 days before starting sorafenib and each week post starting sorafenib, (2) scooping out nut-sized cream with a unique spoon each time, (3) gently applied the cream evenly on symmetrical palms below wrists and symmetrical soles below ankles each time, (4) wore unique cotton gloves immediately after the appalment of cream for 30 minutes each time.
    Arm Title
    10% urea-based cream
    Arm Type
    Active Comparator
    Arm Description
    The B group with BCS plus 10% urea-based cream had the similar interventions as the A group with BCS plus moisturizing cream except being given the cream container with different component (10% urea; Sipharr, Taiwan). The outlook of the containers with the two kinds of cream was the same. All the cream looks white and grey.
    Intervention Type
    Other
    Intervention Name(s)
    best support care
    Intervention Description
    Best support care
    Intervention Type
    Other
    Intervention Name(s)
    moisture cream
    Intervention Description
    BSC plus moisture cream
    Intervention Type
    Other
    Intervention Name(s)
    10% urea-based cream
    Intervention Description
    BSC plus 10% urea-based cream.
    Primary Outcome Measure Information:
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0
    Time Frame
    three days before taking Sorafenib
    Secondary Outcome Measure Information:
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    1 week after taking Sorafenib
    Other Pre-specified Outcome Measures:
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    2 week after taking Sorafenib
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    3 week after taking Sorafenib
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    4 week after taking Sorafenib
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    5 week after taking Sorafenib
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    6 week after taking Sorafenib
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    7 week after taking Sorafenib
    Title
    Scale
    Description
    National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
    Time Frame
    8 week after taking Sorafenib

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    54 Years
    Maximum Age & Unit of Time
    91 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HCC by proof of pathology Presence of tumor thrombus in the main trunk of the portal vein or the first-order branches of the portal vein with minimal ascetics or with no ascetics by abdominal CT scan Child-Pugh liver function class A Planning to receive oral sorafenib 400 mg twice per day Age of 20 or more years old Able to communication in Chinese, Taiwanese or Hakka Exclusion Criteria: Encephalopathy, psychosis, cognition impairment, blindness or hearing impairment Allergic history to urea Present ulceration, blisters, infective problems on the palms or soles Previous surgery, systematic chemotherapy or frequent radial ablation

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Prevention of Hand-foot Skin Reaction

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